Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

NCT00463346 | Completed Phase 3 Results DMC

• 2 other identifiers: 0607001674IP00027
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alcohol Dependence; Schizophrenia

Keywords

Treatment; Alcohol Dependence; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Number of Drinking Days

  12 weeks

• Psychotic Symptoms - Measured Using the PANSS

  The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.

  12 weeks

Study Arms (2)

Acamprosate

EXPERIMENTAL

Acamprosate

Drug: Acamprosate

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Acamprosate DRUG

Acamprosate 1998 mg tid

Also known as: Campral

Acamprosate

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 21 and 65 years of age.
• Patients with a diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder NOS as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) \[22\].
• Patients who are on stable treatment with psychotropic medication \> 2 weeks prior to randomization.
• Patients with current alcohol dependence, with at least one recent episode of heavy drinking (defined as 5 or more drinks per drinking episode) over the past 21 days, and willing to undergo detoxification or self discontinuation (for at least 5 days).
• Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
• Patients who have capacity to provide informed consent prior to entering any study procedure.

You may not qualify if:

• Patients with dementia, amnestic and other cognitive disorders.
• Patients who have unstable medical disease or a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
• Patients with a history of opioid dependence within the past month.
• Patients with a history of intolerance or hypersensitivity to acamprosate.
• Patients who are currently taking disulfiram or naltrexone.
• Patients who based on history or mental status examination are at a significant risk for suicide.
• Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
• Women who are pregnant or nursing, or women of childbearing potential who are sexually active and who do not use adequate contraception, or who are judged to be unreliable in their use of contraception.

Sponsors & Collaborators

• Yale University: lead
• Forest Laboratories: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholism; Schizophrenia

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Elizabeth Ralevski
• Organization: Yale University School Of Medicine Department of Psychiatry

elizabeth.ralevski@yale.edu

2039325711

Study Officials

• Ismene L Petrakis, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 31, 2020
• Results First Posted: January 15, 2016

Record last verified: 2015-12

Locations

US (1)