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Trial record 36 of 450 for:    QUETIAPINE

Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat

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ClinicalTrials.gov Identifier: NCT01971203
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Jack Hirschowitz, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Generalized Anxiety Disorder
Interventions Drug: seroquel xr
Behavioral: CBT
Enrollment 62
Recruitment Details Participants were recruited through the Mount Sinai faculty referrals, medical center employee newsletter, and advertisements in local newspapers, radio, and craigslist.
Pre-assignment Details Ninety-four participants were screened - 10 participants did not meet study eligibility, 22 elected not to continue. 62 participants were randomized, but 7 never returned for the first visit, leaving 55 participants who began treatment.
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT
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Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.

All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time.

matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
Period Title: Overall Study
Started 26 29
Completed 17 21
Not Completed 9 8
Reason Not Completed
Protocol Violation             3             2
Withdrawal by Subject             5             6
Adverse Event             1             0
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT Total
Hide Arm/Group Description

Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.

All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time.

matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy Total of all reporting groups
Overall Number of Baseline Participants 30 32 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 32 participants 62 participants
39.93  (13.68) 39.88  (12.81) 39.90  (13.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Female
17
  56.7%
21
  65.6%
38
  61.3%
Male
13
  43.3%
11
  34.4%
24
  38.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
White
19
  63.3%
22
  68.8%
41
  66.1%
Black
4
  13.3%
4
  12.5%
8
  12.9%
Hispanic
2
   6.7%
3
   9.4%
5
   8.1%
Asian
3
  10.0%
1
   3.1%
4
   6.5%
Other
2
   6.7%
1
   3.1%
3
   4.8%
Unknown
0
   0.0%
1
   3.1%
1
   1.6%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Less than HS
1
   3.3%
0
   0.0%
1
   1.6%
HS
4
  13.3%
2
   6.3%
6
   9.7%
Part college
3
  10.0%
10
  31.3%
13
  21.0%
College
13
  43.3%
15
  46.9%
28
  45.2%
Advanced
8
  26.7%
4
  12.5%
12
  19.4%
Unknown
1
   3.3%
1
   3.1%
2
   3.2%
1.Primary Outcome
Title MADRS
Hide Description Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.
Time Frame baseline and 16 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT
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Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.1  (5.5) 28.6  (6.5)
LOCF (last observation carried forward) 9.1  (6.9) 15.7  (11.9)
2.Secondary Outcome
Title HAM-A
Hide Description Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.
Time Frame baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT
Hide Arm/Group Description:
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.7  (5.2) 17.8  (4.7)
LOCF (last observation carried forward) 5.9  (3.9) 9.4  (7.7)
3.Secondary Outcome
Title Clinical Global Impression Scales for Severity and Improvement
Hide Description The Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).
Time Frame up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT
Hide Arm/Group Description:
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
CGI-S Baseline 4.1  (0.5) 4.3  (0.5)
CGI-S LOCF 2.5  (1.2) 2.9  (1.2)
CGI-I Baseline 3.3  (1.6) 2.7  (1.9)
CGI-I LOCF 1.8  (1.0) 2.4  (1.1)
4.Secondary Outcome
Title Changes in Sexual Functioning Questionnaire (CSFQ)
Hide Description Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent).
Time Frame baseline and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT
Hide Arm/Group Description:
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 15.1  (6.3) 16.6  (5.7)
LOCF 1.8  (0.9) 14.1  (6.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seroquel XR Plus CBT Placebo Plus CBT
Hide Arm/Group Description Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day. matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
All-Cause Mortality
Seroquel XR Plus CBT Placebo Plus CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Seroquel XR Plus CBT Placebo Plus CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Seroquel XR Plus CBT Placebo Plus CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   24/26 (92.31%)   11/29 (37.93%) 
Blood and lymphatic system disorders     
Blood clot  1/26 (3.85%)  0/29 (0.00%) 
Nervous system disorders     
Sedation  24/26 (92.31%)  11/29 (37.93%) 
Psychiatric disorders     
depression  1/26 (3.85%)  0/29 (0.00%) 
The limitations of this research are the small sample size and the high rate of subject drop-out between randomization and initiation of treatment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cindy J. Aaronson, MSW, PhD
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-3169
EMail: cindy.aaronson@mssm.edu
Layout table for additonal information
Responsible Party: Jack Hirschowitz, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01971203     History of Changes
Other Study ID Numbers: GCO 09-0807
First Submitted: October 23, 2013
First Posted: October 29, 2013
Results First Submitted: March 22, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018