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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00197951
First received: September 12, 2005
Last updated: April 20, 2007
Last verified: April 2007

September 12, 2005
April 20, 2007
October 2004
Not Provided
Score opf SCL-90-R psychiatric symptoms scale.
Same as current
Complete list of historical versions of study NCT00197951 on ClinicalTrials.gov Archive Site
  • Alcohol consumption (amount and frequency)
  • Alcohol craving
  • Other substances consumption
  • Alcohol consumption (amount and frequecy)
  • Alcohol craving
  • Other substances consumption
Not Provided
Not Provided
 
Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Depression
  • Anger
  • Anxiety
  • Alcoholism
Drug: Treatment of psychiatric symptoms associated to alcoholism
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00197951
2004-001056-36
Yes
Not Provided
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Pfizer
Principal Investigator: Josep Guardia, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP