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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2004年10月1日最近更新: 2007年4月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 60
试验地点: 2
主要终点: Score opf SCL-90-R psychiatric symptoms scale.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•DSM-IV-TR criteria for alcohol dependence disorder
•Age between 18 -65 years old.
•Score 7 or higher in the GHQ-28 scale.

排除标准

•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

结局指标

主要结局

Score opf SCL-90-R psychiatric symptoms scale.

次要结局

Alcohol craving
Other substances consumption
Alcohol consumption (amount and frequency)

研究者

发起方

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

申办方类型

Other

研究点 (2)

Loading locations...

相似试验

已完成

2 期

Risperidone and Desipramine in Alcohol Use and SchizophreniaDual DiagnosisSchizophreniaAlcoholism

NCT01411085Dartmouth-Hitchcock Medical Center12

已完成

2 期

Antipsychotic Augmentation With L-DopaSchizophrenia

NCT01636037Centre for Addiction and Mental Health13

已完成

不适用

Alcohol Use Disorders in SchizophreniaMood DisordersAlcohol AbuseSchizophreniaAlcohol Dependence

NCT00280813University of Maryland, Baltimore54

已完成

2 期

Testing Doxazosin to Treat Stress Mechanisms in AlcoholismAlcoholism

NCT02989493University of Wisconsin, Madison61

已完成

不适用

A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or DependenceAmphetamine AbuseAmphetamine DependenceMajor Depressive DisorderBipolar Disorder

NCT00377299University of Texas Southwestern Medical Center60