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

This study has been completed.

First Received: September 12, 2005 Last Updated: April 20, 2007 History of Changes

Sponsors and Collaborators:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Pfizer
Information provided by:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:	NCT00197951

Purpose

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.

Condition	Intervention	Phase
Depression Anger Anxiety Alcoholism	Drug: Treatment of psychiatric symptoms associated to alcoholism	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Anxiety Depression

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:

Score opf SCL-90-R psychiatric symptoms scale.

Secondary Outcome Measures:

Alcohol consumption (amount and frequency)
Alcohol craving
Other substances consumption

Estimated Enrollment:	60
Study Start Date:	October 2004
Study Completion Date:	April 2007

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197951

Locations

Spain
Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025

Sponsors and Collaborators

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

Pfizer

Investigators

Principal Investigator:

Josep Guardia, MD

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

More Information

No publications provided

Study ID Numbers:	2004-001056-36
Study First Received:	September 12, 2005
Last Updated:	April 20, 2007
ClinicalTrials.gov Identifier:	NCT00197951 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Psychiatric symptoms associated to alcoholism recovery
Alcoholism treatment
Alcohol craving
Relapse to heavy drinking
Abuse of other substances during alcoholism recovery

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Depression
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Depressive Disorder
Antipsychotic Agents
Serotonin

Behavioral Symptoms
Dopamine
Mental Disorders
Alcoholism
Substance-Related Disorders
Dopamine Agents
Alcohol-Related Disorders
Ziprasidone
Ethanol

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Behavioral Symptoms
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Dopamine Agents
Alcohol-Related Disorders
Ziprasidone
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009