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

NCT00834652 | Completed Phase 4 Results

• 2 other identifiers: R01MH081150DAHBR 96-BHC
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of Beck Depression Inventory-II Scores Over 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.

  Measured at Baseline and 16 Weeks

Study Arms (2)

1

EXPERIMENTAL

Participants will receive sertraline and metformin.

Drug: Sertraline; Drug: Metformin

2

PLACEBO COMPARATOR

Participants will receive sertraline and placebo.

Drug: Sertraline

Interventions

Sertraline DRUG

50 mg once a day, which may be increased to 200 mg once a day

Also known as: Zoloft

1; 2

Metformin DRUG

Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

1

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) greater than 28.7
• Positive screening for depression
• Must live within 100 miles of the St. Louis metropolitan area

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

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

Interventions

Sertraline; Metformin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Nutritional and Metabolic Diseases; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Patrick J. Lustman, Ph.D.
• Organization: Washington University School of Medicine

lustmanp@psychiatry.wustl.edu

3142861320

Study Officials

• Patrick J. Lustman, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: September 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 10, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-08

Locations

US (1)