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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197951
First Posted: September 20, 2005
Last Update Posted: April 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00197951     History of Changes
Other Study ID Numbers: 2004-001056-36
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: April 23, 2007
Last Verified: April 2007

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents