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

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

Status and phase

Completed

Phase 3

Conditions

Alcoholism

Anger

Depression

Anxiety

Treatments

Drug: Treatment of psychiatric symptoms associated to alcoholism

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00197951

2004-001056-36

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18 to 65 years old

Volunteers

No 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