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
  Purpose

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


Condition Intervention Phase
Depression
Drug: Sertraline
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

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 ]

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834652

Contacts
Contact: Billy D. Nix 314-362-3201 NIXD@WUSTL.EDU
Contact: Britt M. Caldwell, MS 314-362-2621 caldwelb@psychiatry.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Investigators
Principal Investigator: Patrick J. Lustman, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Patrick J. Lustman, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00834652     History of Changes
Other Study ID Numbers: R01 MH081150, DAHBR 96-BHC
Study First Received: February 2, 2009
Last Updated: September 18, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
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
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on April 21, 2014