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

Depression Clinical Trial

Official title:

Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197951
• Other study ID #: 2004-001056-36
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 20, 2007
• Start date: October 2004
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Anger
• Anxiety
• Depression

Intervention

Drug:
• Treatment of psychiatric symptoms associated to alcoholism

Locations

Country	Name	City	State
Spain	Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score opf SCL-90-R psychiatric symptoms scale.
Secondary	Alcohol consumption (amount and frequency)
Secondary	Alcohol craving
Secondary	Other substances consumption