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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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

Conditions

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Depression Anger Anxiety Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Treatment of psychiatric symptoms associated to alcoholism

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Josep Guardia, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2004-001056-36

Identifier Type: -

Identifier Source: org_study_id