Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 87 of 450 for:    QUETIAPINE

Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms (Seroquel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00955474
Recruitment Status : Terminated (AstraZeneca halted funding; patent expired for Seroquel (Quetiapine) in 2012)
First Posted : August 10, 2009
Results First Posted : March 28, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder With Psychotic Features
Interventions Drug: Quetiapine
Drug: escitalopram
Drug: Sertraline
Drug: Citalopram
Enrollment 32
Recruitment Details Participants were recruitment through newspaper advertisements in the Boston metro area.
Pre-assignment Details Participants were required to wash-out prior to randomization and study procedures. If the patient was unable to wash-out (by personal choice or doctor's recommendation), they were excluded. Seven subjects withdrew consent prior to randomization.
Arm/Group Title Quetiapine Quetiapine and SSRI
Hide Arm/Group Description

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Period Title: Overall Study
Started 12 13
Completed 5 8
Not Completed 7 5
Reason Not Completed
Physician Decision             7             5
Arm/Group Title Quetiapine Quetiapine and SSRI Total
Hide Arm/Group Description

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
Thirty-two patients were consented and 25 participants were randomized. The remaining 7 participants withdrew consent prior to randomization and the collection of any baseline data.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
13
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
39.25
(25 to 58)
42.85
(21 to 62)
40.32
(21 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
4
  33.3%
4
  30.8%
8
  32.0%
Male
8
  66.7%
9
  69.2%
17
  68.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Hispanic or Latino
2
  16.7%
1
   7.7%
3
  12.0%
Not Hispanic or Latino
8
  66.7%
12
  92.3%
20
  80.0%
Unknown or Not Reported
2
  16.7%
0
   0.0%
2
   8.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   7.7%
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
  30.8%
4
  16.0%
White
9
  75.0%
8
  61.5%
17
  68.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  25.0%
0
   0.0%
3
  12.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 13 participants 25 participants
12 13 25
1.Primary Outcome
Title Depression
Hide Description Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
27  (16.21) 26.73  (6.84)
Last visit Number Analyzed 5 participants 8 participants
9.57  (5.44) 10.14  (8.40)
2.Primary Outcome
Title Psychosis
Hide Description Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Complete missing data for 2 subjects in the quetiapine with SSRI group (11 of 13 have baseline outcome measures). There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
56.09  (7.26) 60.45  (16.49)
Last visit Number Analyzed 5 participants 8 participants
34.25  (25.04) 32.83  (8.98)
3.Secondary Outcome
Title Fasting Blood Glucose
Hide Description Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine and SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: ml/dl
Baseline Number Analyzed 12 participants 11 participants
91.6  (10.2) 89.4  (10.6)
Week 8 Number Analyzed 5 participants 8 participants
89.1  (2.2) 96.8  (19.2)
4.Secondary Outcome
Title CPFQ (Cognitive and Psychological Functioning Questionnaire)
Hide Description Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
30.8  (4.69) 29.3  (9.24)
Last visit Number Analyzed 5 participants 8 participants
23.56  (7.07) 21.00  (6.40)
5.Secondary Outcome
Title RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score
Hide Description Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks.
Time Frame 8
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
77.38  (13.71) 70.00  (16.12)
Last visit Number Analyzed 5 participants 8 participants
77.25  (15.23) 78.29  (16.94)
6.Secondary Outcome
Title RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score
Hide Description RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
83.3  (17.2) 71.1  (14.1)
Week 8 Number Analyzed 5 participants 8 participants
82.8  (14.4) 77.9  (16.2)
7.Secondary Outcome
Title RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.
Hide Description RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
70.6  (15.9) 75.6  (16.1)
Week 8 Number Analyzed 5 participants 8 participants
70.5  (30.8) 78.3  (17.8)
8.Secondary Outcome
Title RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.
Hide Description RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
80.4  (16.2) 77.6  (21.2)
Week 8 Number Analyzed 5 participants 8 participants
87.9  (13.7) 91.1  (7.9)
9.Secondary Outcome
Title RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.
Hide Description RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
95.8  (17.1) 85.4  (15.9)
Week 8 Number Analyzed 5 participants 8 participants
104.6  (21.6) 86.1  (11.0)
10.Secondary Outcome
Title RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.
Hide Description RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
82.4  (21.6) 69.6  (22.3)
Week 8 Number Analyzed 5 participants 8 participants
72.9  (13.7) 74.7  (24.3)
11.Secondary Outcome
Title Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.
Hide Description Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline Number Analyzed 12 participants 11 participants
184.2  (34.4) 171.8  (38.8)
Week 8 Number Analyzed 5 participants 8 participants
188  (2.2) 201.7  (55.8)
12.Secondary Outcome
Title Blood Level of Triglycerides at Baseline and Week 8.
Hide Description Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline Number Analyzed 12 participants 11 participants
144.9  (71.1) 154.25  (80.5)
Week 8 Number Analyzed 5 participants 8 participants
170.6  (125.2) 190.5  (68.5)
13.Secondary Outcome
Title HDL Blood Levels at Baseline and Week 8.
Hide Description HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline Number Analyzed 12 participants 11 participants
47.7  (15.1) 45.3  (6.6)
Week 8 Number Analyzed 5 participants 8 participants
40.8  (13.2) 40.5  (12.2)
14.Secondary Outcome
Title LDL Blood Levels at Baseline and Week 8.
Hide Description LDL levels at Baseline and Week 8. Normal range < 100 mg/dl.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline Number Analyzed 12 participants 11 participants
109  (25.3) 94.6  (27.3)
Week 8 Number Analyzed 5 participants 8 participants
121.1  (39.4) 123.3  (42.2)
15.Secondary Outcome
Title Blood Hemoglobin A1C at Baseline and Week 8.
Hide Description Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Arm/Group Title Quetiapine Quetiapine With SSRI
Hide Arm/Group Description:

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: % glycated hemoglobin
Baseline Number Analyzed 12 participants 11 participants
5.6  (0.5) 5.7  (0.5)
Week 8 Number Analyzed 5 participants 8 participants
5.4  (0.5) 5.8  (0.3)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Quetiapine and SSRI
Hide Arm/Group Description

Patients assigned to receive Quetiapine

•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.

Patients assigned to receive Quetiapine and SSRI

  • Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
  • Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
  • Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
  • Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
All-Cause Mortality
Quetiapine Quetiapine and SSRI
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Quetiapine and SSRI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      1/13 (7.69%)    
Nervous system disorders     
Acute mania  [1]  0/12 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Worsening depression  [2]  1/12 (8.33%)  1 0/13 (0.00%)  0
Increased paranoia and auditory hallucinations  [3]  1/12 (8.33%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
The patient was hospitalized for acute mania and it was considered unrelated.
[2]
Severity of depression resulted in psychiatric hospitalization. Considered to be unrelated to the study.
[3]
The worsening psychosis resulted in psychiatric hospitalization.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Quetiapine Quetiapine and SSRI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      10/13 (76.92%)    
Cardiac disorders     
Light headedness   1/12 (8.33%)  1 1/13 (7.69%)  1
Eye disorders     
Blurred vision   0/12 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Constipation   2/12 (16.67%)  2 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Leg cramps   0/12 (0.00%)  0 2/13 (15.38%)  2
Hand weakness   1/12 (8.33%)  1 0/13 (0.00%)  0
Nervous system disorders     
Fatigue   2/12 (16.67%)  2 5/13 (38.46%)  5
Dizziness   1/12 (8.33%)  1 0/13 (0.00%)  0
Headaches   0/12 (0.00%)  0 1/13 (7.69%)  1
Dry mouth   3/12 (25.00%)  3 2/13 (15.38%)  2
Sweating   0/12 (0.00%)  0 2/13 (15.38%)  2
Carbohydrate cravings   0/12 (0.00%)  0 1/13 (7.69%)  1
Psychiatric disorders     
Excess sedation  [1]  2/12 (16.67%)  2 4/13 (30.77%)  4
Dreaming   0/12 (0.00%)  0 1/13 (7.69%)  1
Depression   0/12 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
Sedation is a common side effect from Seroquel
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D. Matthews, MD
Organization: Massachusetts General Hospital
Phone: 6177249144
EMail: jdmatthews@partners.org
Layout table for additonal information
Responsible Party: John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00955474     History of Changes
Other Study ID Numbers: 2008P001022
First Submitted: August 6, 2009
First Posted: August 10, 2009
Results First Submitted: April 4, 2014
Results First Posted: March 28, 2016
Last Update Posted: April 20, 2017