Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism

Phase 3CompletedNCT00197951

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau60 enrolled

Overview

Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone can improve malfunctioning of these disregulated systems, thereby improving anxiety, depression, anhedonia, anger, and alcohol craving.

60 alcohol-dependent patients will be included, once finished alcohol detoxification treatment.Thirty patients will receive ziprasidone treatment, in progressively increasing doses, starting from 40 mg per day, and the other 30 patients will receive placebo, in a double blind procedure

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression Anger Anxiety Alcoholism

Interventions

Treatment of psychiatric symptoms associated to alcoholismDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * DSM-IV-TR criteria for alcohol dependence disorder * Age between 18 -65 years old. * Score 7 or higher in the GHQ-28 scale. Exclusion Criteria: * More than 30 days without drinking alcohol. * Severe medical disorders. * Psychotic or bipolar disorders severely decompensated requiring antipsychotic medication. * Opiate, cocaine or benzodiazepine dependence disorders, requiring more than one week of detoxification treatment. * Pregnant or lactating women

Locations (1)

Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Score opf SCL-90-R psychiatric symptoms scale.

Secondary Outcomes

Alcohol consumption (amount and frequency)

Alcohol craving

Other substances consumption

Data from ClinicalTrials.gov

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