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

Primary Purpose

Depression, Anger, Anxiety

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Treatment of psychiatric symptoms associated to alcoholism
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Psychiatric symptoms associated to alcoholism recovery, Alcoholism treatment, Alcohol craving, Relapse to heavy drinking, Abuse of other substances during alcoholism recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau

Outcomes

Primary Outcome Measures

Score opf SCL-90-R psychiatric symptoms scale.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
April 20, 2007
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00197951
Brief Title
Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
Official Title
Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anger, Anxiety, Alcoholism
Keywords
Psychiatric symptoms associated to alcoholism recovery, Alcoholism treatment, Alcohol craving, Relapse to heavy drinking, Abuse of other substances during alcoholism recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Treatment of psychiatric symptoms associated to alcoholism
Primary Outcome Measure Information:
Title
Score opf SCL-90-R psychiatric symptoms scale.
Secondary Outcome Measure Information:
Title
Alcohol consumption (amount and frequency)
Title
Alcohol craving
Title
Other substances consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Guardia, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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