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

• 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: Washington University School of Medicine
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Depression	Drug: Sertraline; Drug: Metformin	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent
• Study Start Date: September 2007
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Participants will receive sertraline and metformin.	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
Placebo Comparator: 2; Participants will receive sertraline and placebo.	Drug: Sertraline; 50 mg once a day, which may be increased to 200 mg once a day; Other Name: Zoloft

Outcome Measures

Primary Outcome Measures :

1. Change of Beck Depression Inventory-II Scores Over 16 Weeks [ Time Frame: Measured at Baseline and 16 Weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Patrick J. Lustman, PhD; Washington University School of Medicine

More Information

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00834652
• Other Study ID Numbers: R01MH081150 ( U.S. NIH Grant/Contract ); R01MH081150 ( U.S. NIH Grant/Contract ); DAHBR 96-BHC
• First Posted: February 3, 2009
• Results First Posted: February 28, 2018
• Last Update Posted: September 10, 2018
• Last Verified: August 2018

Keywords provided by Washington University School of Medicine:

Metabolic Diseases; Depressive Disorder, Major; Depressive Disorder; Glucose Metabolism Disorders; Depression Recurrence

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Metformin; Sertraline; Hypoglycemic Agents; Physiological Effects of Drugs; Antidepressive Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents