Trial Outcomes & Findings for Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight (NCT NCT00834652)
NCT ID: NCT00834652
Last Updated: 2018-09-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
206 participants
Primary outcome timeframe
Measured at Baseline and 16 Weeks
Results posted on
2018-09-10
Participant Flow
Participant milestones
| Measure |
Sertraline Plus Metformin
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
|
Sertraline Plus Placebo
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 Study
STARTED
|
104
|
102
|
|
Overall Study
COMPLETED
|
66
|
62
|
|
Overall Study
NOT COMPLETED
|
38
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
Baseline characteristics by cohort
| Measure |
Sertraline Plus Metformin
n=104 Participants
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
|
Sertraline Plus Placebo
n=102 Participants
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
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.67 years
n=5 Participants
|
42.15 years
n=7 Participants
|
42.91 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=5 Participants
|
102 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Marital Status (married)
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Education
|
14.64 years
n=5 Participants
|
14.60 years
n=7 Participants
|
14.62 years
n=5 Participants
|
|
Baseline Body Mass Index (BMI)
|
38.53 kg/m^2
n=5 Participants
|
38.07 kg/m^2
n=7 Participants
|
38.30 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and 16 WeeksBeck 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.
Outcome measures
| Measure |
Sertraline Plus Metformin
n=104 Participants
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
|
Sertraline Plus Placebo
n=102 Participants
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
|
|---|---|---|
|
Change of Beck Depression Inventory-II Scores Over 16 Weeks
BDI Change Scores
|
18.82 units on a scale
Standard Deviation 8.78
|
17.50 units on a scale
Standard Deviation 7.94
|
|
Change of Beck Depression Inventory-II Scores Over 16 Weeks
BDI at Baseline
|
22.68 units on a scale
Standard Deviation 8.00
|
22.03 units on a scale
Standard Deviation 7.71
|
|
Change of Beck Depression Inventory-II Scores Over 16 Weeks
BDI at Week 16
|
3.86 units on a scale
Standard Deviation 4.57
|
4.53 units on a scale
Standard Deviation 4.10
|
Adverse Events
Sertraline Plus Metformin
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Sertraline Plus Placebo
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertraline Plus Metformin
n=104 participants at risk
|
Sertraline Plus Placebo
n=102 participants at risk
|
|---|---|---|
|
Psychiatric disorders
Syncopal episode leading to inpatient hospitalization
|
0.00%
0/104 • 16 weeks
|
0.98%
1/102 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Sertraline Plus Metformin
n=104 participants at risk
|
Sertraline Plus Placebo
n=102 participants at risk
|
|---|---|---|
|
Nervous system disorders
Headache
|
26.9%
28/104 • 16 weeks
|
31.4%
32/102 • 16 weeks
|
|
Nervous system disorders
Insomnia
|
33.7%
35/104 • 16 weeks
|
32.4%
33/102 • 16 weeks
|
|
Nervous system disorders
Fatigue
|
40.4%
42/104 • 16 weeks
|
35.3%
36/102 • 16 weeks
|
|
Ear and labyrinth disorders
Dizziness
|
8.7%
9/104 • 16 weeks
|
7.8%
8/102 • 16 weeks
|
|
General disorders
Weakness
|
13.5%
14/104 • 16 weeks
|
9.8%
10/102 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
28/104 • 16 weeks
|
21.6%
22/102 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
14.4%
15/104 • 16 weeks
|
10.8%
11/102 • 16 weeks
|
|
Gastrointestinal disorders
Flatulence
|
24.0%
25/104 • 16 weeks
|
20.6%
21/102 • 16 weeks
|
|
Gastrointestinal disorders
Indigestion
|
25.0%
26/104 • 16 weeks
|
19.6%
20/102 • 16 weeks
|
|
Gastrointestinal disorders
Bloating
|
23.1%
24/104 • 16 weeks
|
13.7%
14/102 • 16 weeks
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
7/104 • 16 weeks
|
7.8%
8/102 • 16 weeks
|
|
Vascular disorders
Sexual Dysfunction
|
19.2%
20/104 • 16 weeks
|
16.7%
17/102 • 16 weeks
|
|
Nervous system disorders
Sweating
|
26.0%
27/104 • 16 weeks
|
18.6%
19/102 • 16 weeks
|
|
Nervous system disorders
Tremors
|
9.6%
10/104 • 16 weeks
|
7.8%
8/102 • 16 weeks
|
|
General disorders
Dry mouth
|
17.3%
18/104 • 16 weeks
|
12.7%
13/102 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.7%
8/104 • 16 weeks
|
11.8%
12/102 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Itching
|
15.4%
16/104 • 16 weeks
|
9.8%
10/102 • 16 weeks
|
|
Ear and labyrinth disorders
Change in Hearing
|
7.7%
8/104 • 16 weeks
|
7.8%
8/102 • 16 weeks
|
Additional Information
Patrick J. Lustman, Ph.D.
Washington University School of Medicine
Phone: 3142861320
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place