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NCT00006204 · ClinicalTrials.gov registry record · Phase 4

Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)

A Phase 4 study of Depression and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
Phase 4
Development phase
106
Enrollment target
1
Study location

NCT00006204 is a Phase 4 study of Depression and Alcoholism that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 106 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00006204, a Phase 4 study of Depression and Alcoholism, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Phase 4
Development phase
106 participants
Enrollment target
1
Study location

Study Summary

This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the first month and every two weeks during the second through sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will complete follow-up assessments at 9 and 12 months.

Interventions

  • DRUG naltrexone (Revia)
  • DRUG fluoxetine (Prozac)

Study Locations (1)

Pennsylvania

  • Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2000-03
Est. Completion 2006-01
Phase Phase 4

What the Registry Record Tells You About NCT00006204

The ClinicalTrials.gov registry entry for NCT00006204 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which naltrexone (Revia) is the first listed.

NCT00006204 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00006204 about?

NCT00006204 is a clinical study titled "Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)". This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the...

What is the current status of trial NCT00006204?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 106 participants. The study started on 2000-03. Estimated completion is 2006-01.

What conditions does trial NCT00006204 study?

This clinical trial studies the following conditions: Depression, Alcoholism, Alcohol Dependence.

What interventions are being tested in trial NCT00006204?

The interventions under investigation include: naltrexone (Revia) (DRUG), fluoxetine (Prozac) (DRUG).

Who is sponsoring clinical trial NCT00006204?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00006204 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.