CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23 enrolled
Drug / intervention
Acamprosate +1 moredrug
Likely dose
Acamprosate 1998 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00463346
NCT00463346Phase 3Completed
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Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Yale University·interventional·Posted Apr 20, 2007·Updated Mar 31, 2020

In Brief

A Phase 3 clinical trial evaluating Acamprosate and Placebo for Alcohol Dependence and Schizophrenia. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate the safety and efficacy of acamprosate for patients with alcohol dependence and comorbid schizophrenia spectrum disorders. * 1: Relative to placebo, acamprosate will significantly increase cumulative days of abstinence in recently detoxified alcohol dependent schizophrenia patients measured by Timeline Follow-Back (TLFB) method. * 2: Acamprosate will have no significant effect on the psychotic symptoms in schizophrenia patients with alcohol dependence as measured by the Positive and Negative Syndrome Scale (PANSS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence, Schizophrenia
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2007
Enrollment StartSep 1, 2006
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 19.2 years ago

Interventions

Acamprosatedrug

Acamprosate 1998 mg tid

Placebodrug

Placebo