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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00834652
First received: February 2, 2009
Last updated: September 18, 2009
Last verified: September 2009

February 2, 2009
September 18, 2009
September 2007
May 2012   (final data collection date for primary outcome measure)
Treatment of major depressive disorder (MDD) (acute phase) and prevention of MDD recurrence (maintenance phase) [ Time Frame: Measured over 40 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00834652 on ClinicalTrials.gov Archive Site
  • Insulin resistance (IR), glycemic control, anthropometrics and body composition, and cortisol levels [ Time Frame: Measured over 40 weeks ] [ Designated as safety issue: No ]
  • Value of reducing IR for predicting reduction in depression symptoms and time-to-recurrence (TTR) [ Time Frame: Measured over 40 weeks ] [ Designated as safety issue: No ]
  • Sustained IR reduction during the depression-free interval following treatment [ Time Frame: Measured over 40 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent

This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.

Current depression treatments are not effective for approximately one-half of overweight people, and depression eventually returns in approximately one-third of those overweight people whose initial treatment is effective. One possible reason for these treatment failures is that overweight people often experience a condition called insulin resistance (IR), which can lead to type 2 diabetes, an associated disease that might also affect depression treatment. IR results in elevated blood sugar levels that may interfere with medications used to treat depression. Metformin, a medication commonly used to treat diabetes, reduces blood sugar levels. This study will examine whether taking metformin with the antidepressant medication sertraline will enhance the effectiveness of sertraline in people who are overweight and depressed.

Participation in this study will be divided into two phases lasting a total of 40 weeks. Phase 1 will last 16 weeks and include baseline testing and seven scheduled study visits. During this phase, participants will be randomly assigned to receive either sertraline and metformin or sertraline and placebo on a daily basis. The baseline visit will include the following tests and measures: an electrocardiogram (EKG), which will measure the electrical activity in the heart; an oral glucose tolerance test (OGTT), which will measure how a person's body breaks down glucose; a blood test, which will measure lipids, hemoglobin A1C, and other cardiometabolic risk factors; a dual energy x-ray absorptimetry (DEXA) scan, which will measure body fat; a pregnancy test for women; measurements of vital signs, height, weight, waist-to-hip ratio, and waist circumference; and questionnaires concerning health, medication use, physical activity, diet, and mood. Some of the questionnaires will be administered through interviews with a researcher. During the study visits, which will occur every 2 weeks, participants will complete questionnaires, unused medication will be collected, and new medication will be handed out. At Week 8, participants will provide an additional blood sample by finger stick. At the end of Phase 1, participants will undergo repeat baseline testing.

Participants whose depression has improved after Phase 1 will be eligible to continue to Phase 2 of the study, which will determine the longer term effects of taking metformin with sertraline. Phase 2 of the study will last 24 weeks, with study visits occurring monthly. During the study visits, participants will complete questionnaires again, and medication will be collected and handed out. At Weeks 24 and 32, participants will provide blood samples by finger stick. After completing Phase 2, participants will again undergo repeat baseline testing.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: Sertraline
    50 mg once a day, which may be increased to 200 mg once a day
    Other Name: Zoloft
  • Drug: Metformin
    Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily
  • Experimental: 1
    Participants will receive sertraline and metformin.
    Interventions:
    • Drug: Sertraline
    • Drug: Metformin
  • Placebo Comparator: 2
    Participants will receive sertraline and placebo.
    Intervention: Drug: Sertraline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body mass index (BMI) greater than 28.7
  • Positive screening for depression
  • Must live within 100 miles of the St. Louis metropolitan area

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Known hypersensitivity to sertraline or metformin
  • Recent history of heart attack or unstable heart disease
  • Severe liver disease or kidney impairment, defined by a serum creatine level above 3 mg/dL
  • Psychiatric disorder thought to affect management, such as schizophrenia, or alcohol or drug dependence
Both
20 Years to 60 Years
No
Contact: Billy D. Nix 314-362-3201 NIXD@WUSTL.EDU
Contact: Britt M. Caldwell, MS 314-362-2621 caldwelb@psychiatry.wustl.edu
United States
 
NCT00834652
R01 MH081150, DAHBR 96-BHC
No
Patrick J. Lustman, PhD, Washington University School of Medicine
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Patrick J. Lustman, PhD Washington University School of Medicine
National Institute of Mental Health (NIMH)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP