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

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

Overview[ - collapse ][ - ]

Purpose	This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.
Condition	Depression
Intervention	Drug: Sertraline Drug: Metformin
Phase	Phase 4
Sponsor	National Institute of Mental Health (NIMH)
Responsible Party	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier	NCT00834652
First Received	February 2, 2009
Last Updated	September 18, 2009
Last verified	September 2009

Tracking Information[ + expand ][ + ]

First Received Date	February 2, 2009
Last Updated Date	September 18, 2009
Start Date	September 2007
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
Official Title	Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent
Brief Summary	This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Depression
Intervention	Drug: Sertraline 50 mg once a day, which may be increased to 200 mg once a day Other Names: ZoloftDrug: Metformin Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily
Study Arm (s)	Experimental: 1 Participants will receive sertraline and metformin. Placebo Comparator: 2 Participants will receive sertraline and placebo.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	200
Estimated Completion Date	December 2012
Estimated Primary Completion Date	May 2012
Eligibility Criteria	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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Billy D. Nix 314-362-3201 NIXD@WUSTL.EDU
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00834652
Other Study ID Numbers	R01 MH081150
Has Data Monitoring Committee	No
Information Provided By	National Institute of Mental Health (NIMH)
Study Sponsor	National Institute of Mental Health (NIMH)
Collaborators	Not Provided
Investigators	Principal Investigator: Patrick J. Lustman, PhD Washington University School of Medicine
Verification Date	September 2009

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