NCT00438776已完成3 期
Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling
Lindner Center of HOPE1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
研究概览
简要总结
The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of olanzapine in treating pathological gambling.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients aged 18- 75 years of age.
- •Patients will have problematic gambling behavior of at least 6 months duration that meets the DSM-IV definition of pathological gambling and a South Oaks Gambling Screen Score greater than
- •All patients will have a complete medical and psychiatric history, physical examination, laboratories, and ECG before study entry.
- •Baseline laboratory values and ECG must be normal, or abnormalities must be clinically insignificant.
- •Patients will not have received any psychotropic medication for at least one week prior to the first study visit.
排除标准
- •Patients who have any significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination.
- •Patients who are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit).
- •Patients who have ever had psychotic symptoms, who have ever met DSM-IV criteria for a manic episode (i.e., have bipolar I disorder), or who have met criteria for DSM-IV psychoactive substance dependence in the past 1 month.
- •Patients who meet DSM-IV criteria for antisocial or borderline personality disorder.
- •Patients who use any medications which, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with olanzapine. For example, patients taking diet pills or stimulants will not be enrolled.
- •Patients who have taken any psychiatric medication within 7 days prior to the screening assessment.
- •Patients who have a history of hypersensitivity to olanzapine.
- •Patients who display clinically significant suicidal ideation.
- •Patients who have recently (within the past 3 months) begun any type of non-pharmacologic treatment for pathological gambling (including psychotherapy, behavior therapy, group therapy, or family therapy). This does not exclude participation in support groups (e.g., Gamblers Anonymous.) Patients who have been involved in long-standing psychological therapies (e.g., psychotherapy for at least the last 3 months) will be permitted to continue in that therapy provided that no new therapeutic technique or increase in frequency of psychotherapy occurs concurrent with the study.
- •Patients who exhibit or suggest that they may display behavior that will not be conducive to the study procedures.
研究组 & 干预措施
olanzapine
Active Comparator
active zyprexa (olanzapine)
干预措施: olanzapine (Drug)
sugar pill
Placebo Comparator
Placebo (fake pill)
干预措施: sugar pill (Drug)
结局指标
主要结局
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
时间窗: per protocol
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and AdolescentsEating DisorderNCT01184443Children's Hospital of Eastern Ontario38
已完成
3 期
Efficacy and Safety of Olanzapine in Patients With Borderline Personality DisorderBorderline Personality DisorderNCT00088036Eli Lilly and Company450
已完成
3 期
Olanzapine in Patients With Borderline Personality DisorderBorderline Personality DisorderNCT00091650Eli Lilly and Company300
终止
不适用
Safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in colorectal cancer patientsNeoplasmsKCT0003288Chungnam National University Hospital330
终止
4 期
Oral Olanzapine Versus Haloperidol or DiazepamAcute AgitationBehavioural EmergencyNCT03246620The University of Hong Kong12