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Completed

NCT Number: NCT00197951

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

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.

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Key information

Conditions

Depression Alcohol-Related Disorders Alcoholism Anger Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Barcelona, 08025, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of psychiatric symptoms associated to alcoholism

Drug

Primary outcomes

  1. Score opf SCL-90-R psychiatric symptoms scale.

Secondary outcomes

  1. Alcohol consumption (amount and frequency)

  2. Alcohol craving

  3. Other substances consumption

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Pfizer

Registry information

Official study title

Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder.

Important dates

Study start
2004
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Apr 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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