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Sponsors and Collaborators: |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Pfizer |
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Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT00197951 |
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.
Condition | Intervention | Phase |
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Depression Anger Anxiety Alcoholism |
Drug: Treatment of psychiatric symptoms associated to alcoholism |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology, Not Being a Severe Mental Disorder, Associated to Alcohol Dependence Disorder. |
Estimated Enrollment: | 60 |
Study Start Date: | October 2004 |
Study Completion Date: | April 2007 |
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Unidad de Conductas Adictivas//Servicio de Psiquiatría//Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08025 |
Principal Investigator: | Josep Guardia, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Study ID Numbers: | 2004-001056-36 |
Study First Received: | September 12, 2005 |
Last Updated: | April 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00197951 |
Health Authority: | Spain: Spanish Agency of Medicines |
Psychiatric symptoms associated to alcoholism recovery Alcoholism treatment Alcohol craving Relapse to heavy drinking Abuse of other substances during alcoholism recovery |
Dopamine Depression Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin |
Alcohol-Related Disorders Ziprasidone Depressive Disorder Serotonin Ethanol Behavioral Symptoms |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |