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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197951

Enrollment

Registered

2005-09-20

Start date

2004-10-31

Completion date

2007-04-30

Last updated

2007-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Anger, Anxiety, Depression

Keywords

Psychiatric symptoms associated to alcoholism recovery, Alcoholism treatment, Alcohol craving, Relapse to heavy drinking, Abuse of other substances during alcoholism recovery

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

Interventions

DRUGTreatment of psychiatric symptoms associated to alcoholism

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Score opf SCL-90-R psychiatric symptoms scale.	—

Secondary

Measure	Time frame
Alcohol consumption (amount and frequency)	—
Alcohol craving	—
Other substances consumption	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026