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Trial record 17 of 692 for:    BDI | "Depression"

Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight

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ClinicalTrials.gov Identifier: NCT00834652
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : February 28, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Sertraline
Drug: Metformin
Enrollment 206

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline Plus Metformin Sertraline Plus Placebo
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Participants will receive sertraline and metformin for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

Participants will receive sertraline and placebo for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Period Title: Overall Study
Started 104 102
Completed 66 62
Not Completed 38 40
Arm/Group Title Sertraline Plus Metformin Sertraline Plus Placebo Total
Hide Arm/Group Description

Participants will receive sertraline and metformin for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

Participants will receive sertraline and placebo for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Total of all reporting groups
Overall Number of Baseline Participants 104 102 206
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 104 participants 102 participants 206 participants
43.67
(20 to 60)
42.15
(22 to 58)
42.91
(20 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 102 participants 206 participants
Female
86
  82.7%
85
  83.3%
171
  83.0%
Male
18
  17.3%
17
  16.7%
35
  17.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants 102 participants 206 participants
104 102 206
Marital Status (married)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 102 participants 206 participants
48 45 93
Education  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 104 participants 102 participants 206 participants
14.64
(10 to 18)
14.60
(8 to 20)
14.62
(8 to 20)
Baseline Body Mass Index (BMI)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 104 participants 102 participants 206 participants
38.53
(27.44 to 59.23)
38.07
(27.80 to 58.42)
38.30
(27.44 to 59.23)
1.Primary Outcome
Title Change of Beck Depression Inventory-II Scores Over 16 Weeks
Hide Description Beck Depression Inventory-II (BDI) scores 0-63, minimum score =0, maximum score =63, Higher scores represent worse outcome. Baseline scores are compared to scores after treatment.
Time Frame Measured at Baseline and 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Plus Metformin Sertraline Plus Placebo
Hide Arm/Group Description:

Participants will receive sertraline and metformin for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

Participants will receive sertraline and placebo for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Overall Number of Participants Analyzed 104 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
BDI Change Scores 18.82  (8.78) 17.50  (7.94)
BDI at Baseline 22.68  (8.00) 22.03  (7.71)
BDI at Week 16 3.86  (4.57) 4.53  (4.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline Plus Metformin, Sertraline Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sertraline Plus Metformin Sertraline Plus Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Sertraline Plus Metformin Sertraline Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline Plus Metformin Sertraline Plus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      1/102 (0.98%)    
Psychiatric disorders     
Syncopal episode leading to inpatient hospitalization [1]  0/104 (0.00%)  0 1/102 (0.98%)  1
[1]
Participant (pt) seen in ER- had a syncopal episode and fell at home. Later possible persecutory delusions & hyper-religiosity symptoms questioned; pt found walking “aimlessly” in traffic- transferred to psychiatric unit for admission and evaluation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline Plus Metformin Sertraline Plus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/104 (42.31%)      41/102 (40.20%)    
Ear and labyrinth disorders     
Dizziness  9/104 (8.65%)  8/102 (7.84%) 
Change in Hearing  8/104 (7.69%)  8/102 (7.84%) 
Gastrointestinal disorders     
Diarrhea  28/104 (26.92%)  22/102 (21.57%) 
Nausea  15/104 (14.42%)  11/102 (10.78%) 
Flatulence  25/104 (24.04%)  21/102 (20.59%) 
Indigestion  26/104 (25.00%)  20/102 (19.61%) 
Bloating  24/104 (23.08%)  14/102 (13.73%) 
Anorexia  7/104 (6.73%)  8/102 (7.84%) 
Constipation  8/104 (7.69%)  12/102 (11.76%) 
General disorders     
Weakness  14/104 (13.46%)  10/102 (9.80%) 
Dry mouth  18/104 (17.31%)  13/102 (12.75%) 
Nervous system disorders     
Headache  28/104 (26.92%)  32/102 (31.37%) 
Insomnia  35/104 (33.65%)  33/102 (32.35%) 
Fatigue  42/104 (40.38%)  36/102 (35.29%) 
Sweating  27/104 (25.96%)  19/102 (18.63%) 
Tremors  10/104 (9.62%)  8/102 (7.84%) 
Skin and subcutaneous tissue disorders     
Skin Itching  16/104 (15.38%)  10/102 (9.80%) 
Vascular disorders     
Sexual Dysfunction  20/104 (19.23%)  17/102 (16.67%) 
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
Name/Title: Patrick J. Lustman, Ph.D.
Organization: Washington University School of Medicine
Phone: 3142861320
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00834652     History of Changes
Other Study ID Numbers: R01MH081150 ( U.S. NIH Grant/Contract )
R01MH081150 ( U.S. NIH Grant/Contract )
DAHBR 96-BHC
First Submitted: February 2, 2009
First Posted: February 3, 2009
Results First Submitted: August 8, 2016
Results First Posted: February 28, 2018
Last Update Posted: September 10, 2018