Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
NCT00197951
Last updated date
ABOUT THIS STUDY
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.
Study Location
Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau
Barcelona, , 08025, Spain
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Anger, Anxiety, Alcoholism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Depression, Anger, Anxiety, AlcoholismClinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
NCT00197951
- Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism | |||
| Official Title ICMJE | Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder. | |||
| 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 | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Treatment of psychiatric symptoms associated to alcoholism | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 60 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | April 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Spain | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00197951 | |||
| Other Study ID Numbers ICMJE | 2004-001056-36 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | |||
| Verification Date | April 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||