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

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

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 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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834652


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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00834652     History of Changes
Other Study ID Numbers: R01MH081150 ( U.S. NIH Grant/Contract )
R01MH081150 ( U.S. NIH Grant/Contract )
DAHBR 96-BHC
First Posted: February 3, 2009    Key Record Dates
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