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Trial record 1 of 1 for:    NCT00197951
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Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism

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ClinicalTrials.gov Identifier: NCT00197951
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 23, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 23, 2007
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Score opf SCL-90-R psychiatric symptoms scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2007)
  • Alcohol consumption (amount and frequency)
  • Alcohol craving
  • Other substances consumption
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Alcohol consumption (amount and frequecy)
  • Alcohol craving
  • Other substances consumption
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
Official Title  ICMJE Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Anger
  • Anxiety
  • Alcoholism
Intervention  ICMJE Drug: Treatment of psychiatric symptoms associated to alcoholism
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00197951
Other Study ID Numbers  ICMJE 2004-001056-36
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Josep Guardia, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date April 2007

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