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Trial record 23 of 450 for:    QUETIAPINE

Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD

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ClinicalTrials.gov Identifier: NCT02720198
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : July 2, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Forest Laboratories
Institute for Advanced Medical Research, Alpharetta, GA
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Levomilnacipran
Drug: Quetiapine
Enrollment 60
Recruitment Details Potential participants were identified by self-referral via the printed ad, phone script, the patients’ physicians, local health providers, mental health providers, or Duke providers. Others were recommended by PI or Study Coordinator. They assessed and screened at 2 sites, an university hospital and a clinic of the research institute.
Pre-assignment Details One subject was lost to follow up after screening.
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8. Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Period Title: Overall Study
Started 29 31
Completed 29 30
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Levomilnacipran Quetiapine Total
Hide Arm/Group Description Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8. Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI. Total of all reporting groups
Overall Number of Baseline Participants 29 31 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  96.6%
30
  96.8%
58
  96.7%
>=65 years
1
   3.4%
1
   3.2%
2
   3.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 31 participants 60 participants
45.34  (14.28) 46.13  (11.17) 45.75  (12.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Female
20
  69.0%
20
  64.5%
40
  66.7%
Male
9
  31.0%
11
  35.5%
20
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Hispanic or Latino
0
   0.0%
1
   3.2%
1
   1.7%
Not Hispanic or Latino
29
 100.0%
30
  96.8%
59
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
  69.0%
25
  80.6%
45
  75.0%
White
9
  31.0%
4
  12.9%
13
  21.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   6.5%
2
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 31 participants 60 participants
29 31 60
Baseline SSRI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Escitalopram
9
  31.0%
3
   9.7%
12
  20.0%
Fluoxetine
3
  10.3%
10
  32.3%
13
  21.7%
Sertraline
5
  17.2%
6
  19.4%
11
  18.3%
Citalopram
8
  27.6%
5
  16.1%
13
  21.7%
Paroxetine
3
  10.3%
7
  22.6%
10
  16.7%
Unknown
1
   3.4%
0
   0.0%
1
   1.7%
Baseline Dose of SSRI  
Mean (Standard Deviation)
Unit of measure:  Dose of medication, mg
Number Analyzed 29 participants 31 participants 60 participants
mg(Escitalopram) 18.89  (3.333) 16.67  (5.774) 18.33  (3.892)
mg(Fluoxetine) 53.33  (23.094) 42.00  (6.325) 44.62  (11.983)
mg(Sertraline) 170.00  (27.386) 150.00  (31.623) 159.09  (30.151)
mg(Citalopram) 21.25  (8.345) 28.00  (10.954) 23.85  (9.608)
mg(Paroxetine) 40.00  (0.000) 51.43  (15.736) 48.00  (13.984)
1.Primary Outcome
Title Changes of Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Hide Description A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Total scores will range from 0 to 60. Higher scores indicate greater severity of depressive episodes.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available on some participants.
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 26 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-5.81  (6.080) -6.97  (7.632)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.159
Confidence Interval (2-Sided) 95%
-2.518 to 4.836
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.834
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Response Rate
Hide Description Remission was defined as [>or=50% reduction in MADRS score with MADRS <or=10] and response was defined as [>or=50% reduction in MADRS with MADRS >10]. Response rate included remission and response.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available on some participants.
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 26 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.5%
7
  23.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.492
Confidence Interval (2-Sided) 95%
0.101 to 2.388
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.806
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Remission Rate
Hide Description Remission was defined as [>or=50% reduction in MADRS score with MADRS <or=10]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available on some participants.
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 26 30
Measure Type: Count of Participants
Unit of Measure: Participants
2
   7.7%
3
  10.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.451
Confidence Interval (2-Sided) 95%
0.109 to 1.866
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.724
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Changes in Neurocognition by Changes in Scores on Reyes Verbal Learning Test
Hide Description Number of words correctly recalled by the respondent is recorded. 1 point for each word correctly recalled. Total score range of 0-40. Higher scores mean better cognitive function.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.28  (5.694) 2.90  (5.255)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.664
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.624
Confidence Interval (2-Sided) 95%
-3.484 to 2.236
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.428
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Changes in Neurocognition by Changes in Scores on Scores on Digit Symbol Substitution Test (DSST)
Hide Description DSST measures working memory and visuospatial processing. 1 point for each object correctly substituted from number to each matched symbol. Total score range of 0-89. Higher scores mean better cognitive function.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.21  (9.321) 0.87  (7.431)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.292
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.34
Confidence Interval (2-Sided) 95%
-2.070 to 6.750
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.199
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects With Global Improvement in Scores on Clinical Global Impression Scale- Severity (CGI-S)
Hide Description CGI-S is a 7 point scale that assess the severity of illness and requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician’s view of the patient’s global functioning. Total score range of 0-7.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 29 30
Measure Type: Count of Participants
Unit of Measure: Participants
13
  44.8%
13
  43.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.063
Confidence Interval (2-Sided) 95%
0.380 to 2.971
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.525
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects With General Improvement in Scores on Clinical Global Impression Scale- Improvement (CGI-I)
Hide Description CGI-I a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician’s view of the patient’s global functioning. Total score range of 0-7.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available for some participants.
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 27 30
Measure Type: Count of Participants
Unit of Measure: Participants
21
  77.8%
24
  80.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.875
Confidence Interval (2-Sided) 95%
0.245 to 3.129
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.650
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Changes of Anxiety Symptoms in Scores on Hamilton Anxiety Rating Scale (HAM-A)
Hide Description A questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score range of 0-48. A higher score indicates greater anxiety.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available for all subjects.
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 28 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.89  (4.969) -5.53  (5.859)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
-1.211 to 4.492
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.423
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Changes of Quality of Life in Scores on Sheehan Disability Scale (SDS) Total
Hide Description A self-reported brief scale to assess impairment of work/school, social life and family and home. Total score range of 0-30. A higher score indicates greater impairment.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.79  (6.477) -0.10  (8.126)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.693
Confidence Interval (2-Sided) 95%
-7.520 to 0.134
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.910
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Changes in Scores on Apathy Evaluation Scale (AES).
Hide Description Self-Administered assessment measuring lack of motivation not attributable to diminished level of consciousness, cognitive impairment, or emotional distress. Total scores range from 0-54. Higher scores indicate greater apathy.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.07  (8.689) -1.83  (7.852)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.913
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.236
Confidence Interval (2-Sided) 95%
-4.559 to 4.088
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.158
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Changes in Sexual Dysfunction by Changes in Scores on Arizona Sexual Experience Scale (ASEX)
Hide Description ASEX is scale for sexual dysfunction to assess safety and tolerability of medication. Total scores range from 5-30. Higher scores indicate greater sexual dysfunction.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description:
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.76  (2.923) -0.30  (4.829)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levomilnacipran, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.459
Confidence Interval (2-Sided) 95%
-2.540 to 1.623
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.035
Estimation Comments [Not Specified]
Time Frame Screening to Week 9
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levomilnacipran Quetiapine
Hide Arm/Group Description Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8. Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
All-Cause Mortality
Levomilnacipran Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Levomilnacipran Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levomilnacipran Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   16/29 (55.17%)   22/31 (70.97%) 
Gastrointestinal disorders     
Nausea *  4/29 (13.79%)  4/31 (12.90%) 
General disorders     
Increase Appetite *  0/29 (0.00%)  3/31 (9.68%) 
Weight Gain *  1/29 (3.45%)  3/31 (9.68%) 
Weight Loss *  1/29 (3.45%)  0/31 (0.00%) 
Dry Mouth *  0/29 (0.00%)  1/31 (3.23%) 
Sweating *  3/29 (10.34%)  0/31 (0.00%) 
Nervous system disorders     
Headache *  6/29 (20.69%)  2/31 (6.45%) 
Drowsiness *  2/29 (6.90%)  12/31 (38.71%) 
Dizziness *  0/29 (0.00%)  1/31 (3.23%) 
Confusion *  0/29 (0.00%)  2/31 (6.45%) 
Renal and urinary disorders     
Dysuria *  2/29 (6.90%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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: Dr. Narei Hong
Organization: Duke University Medical Center
Phone: 984-215-8493
EMail: narei.hong@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02720198     History of Changes
Other Study ID Numbers: Pro00064983
First Submitted: March 16, 2016
First Posted: March 25, 2016
Results First Submitted: June 12, 2019
Results First Posted: July 2, 2019
Last Update Posted: August 14, 2019