Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

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 last a total of 16 weeks and will include baseline testing
      and ten scheduled study visits. 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,
      glycosylated 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.
    

Intervention name(s): Sertraline; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg once a day, which may be increased to 200 mg once a day; Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily
Other intervention name(s): Zoloft
Intervention MeSH terms: Metformin; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Diseases; Depressive Disorder, Major; Depressive Disorder; Glucose Metabolism Disorders; Depression Recurrence