Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
Phase 3
Completed
- Conditions
- DepressionAngerAnxietyAlcoholism
- Registration Number
- NCT00197951
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Score opf SCL-90-R psychiatric symptoms scale.
- Secondary Outcome Measures
Name Time Method Alcohol consumption (amount and frequency) Alcohol craving Other substances consumption
Trial Locations
- Locations (1)
Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain