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Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism

NCT00452543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-07-09

Study results available
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Summary

This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.

Conditions

Interventions

DRUG

acamprosate

Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.

DRUG

escitalopram

Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.

BEHAVIORAL

Medical management

Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).

DRUG

Placebo

Placebo, 2 capsules PO TID, for 12 weeks

Sponsors & Collaborators

  • National Alliance for Research on Schizophrenia and Depression

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Janet M Witte, MD · Massachusetts General Hospital

  • Nicholas Bolo, PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452543 on ClinicalTrials.gov