Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
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).
|Alcohol Dependence Schizophrenia||Drug: Acamprosate Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism|
- Number of Drinking Days [ Time Frame: 12 weeks ]
- Psychotic Symptoms - Measured Using the PANSS [ Time Frame: 12 weeks ]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.
|Study Start Date:||September 2006|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Acamprosate 1998 mg tid
Other Name: Campral
Placebo Comparator: placebo
Alcohol use disorders (AUD) are common comorbid conditions in patients with schizophrenia, and they cause a negative impact on the expression and course of schizophrenia. Improvements have been reported after attaining abstinence from alcohol, suggesting that effective treatments for AUD lead to clinically meaningful results. Acamprosate is a recently approved treatment for alcoholism, and it may be advantageous over other treatments since is not metabolized in the liver, and it has been used safely with other psychotropic medications. Therefore, acamprosate would be a promising treatment in schizophrenia patients. However, there are only few reports in the current literature evaluating the efficacy of medications available for the treatment of alcoholism in patients with schizophrenia, and the efficacy and safety of acamprosate have never been studied in this vulnerable group of patients.
This is a 12-week, randomized, double blind, placebo controlled trial of acamprosate (666 mg tid) in addition to neuroleptics in 30 recently abstinent (>5 days) schizophrenia patients with comorbid alcohol dependence.
The study will be conducted at the West Haven, CT VA with support from Forest Laboratories. Patients who are between 21 and 65, with a diagnosis of schizophrenia spectrum disorder, (on stable psychotropic treatment > 2 weeks) and with current alcohol dependence (>1 recent episode of heavy drinking) will be included. Patients will be willing to undergo detoxification or self discontinuation >2weeks prior to the randomization. Main outcome variables include the TLFB method to document the degree of daily alcohol consumption, and PANSS, to assess the psychotic symptoms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463346
|United States, Connecticut|
|VA Connecticut Healthcare System|
|WEst Haven, Connecticut, United States, 06516|
|Principal Investigator:||Ismene L Petrakis, MD||Yale University|