A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Clinical Global Improvement-21 Anxiety scale (CGI-21 Anxiety)
研究概览
简要总结
The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).
详细描述
Methods and Procedures:
This is a randomized, double-blind, placebo controlled, parallel-group, 3 site, 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I, II, or not otherwise specified (NOS) disorder, a lifetime panic or generalized anxiety disorder, and current, at least moderately, severe anxiety symptoms. Approximately 90 subjects will be enrolled to obtain 60 subjects who complete the 8-week trial. Subjects will be randomized to risperidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed except for as needed (prn) lorazepam during the first two weeks for the management of affective and anxiety symptoms, and prn zolpidem and zaleplon throughout the study for the management of insomnia. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.
Medication Dosing:
Risperidone will be administered at an initial dose of 0.5 to 1 mg/day and will be titrated upward to a dose considered optimal by the investigator based on the subject's clinical response and adverse events, but not to exceed 2.0 mg/day by the end of the second week. Subsequently, risperidone may be increased based on clinical response and tolerability to a maximum of 4.0 mg/day. As needed study-prescribed (prn) use of lorazepam will be allowed for the management of affective and anxiety symptoms for the first two weeks of the study; a maximum of 2 mg per day will be allowed during the first week, and a maximum of 1 mg per day will be allowed during the second week. During the second week, the subject must be tapered off the lorazepam. For the final six weeks of the study, no lorazepam will be permitted. Zolpidem (10-20 mg/day) or zaleplon (10-20 mg/day) will be allowed for management of insomnia, and benztropine (0.5 - 3.0 mg/day) will be allowed for management of extrapyramidal symptoms. The latter three agents will be permitted throughout the study.
From week 2 on, any medications with psychotropic effects are prohibited.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 18 years of age or older.
- •Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
- •Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) .
- •Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP <
- •Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S >
- •Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline.
- •Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
- •If female, subjects must be:
- •postmenopausal,
- •surgically incapable of childbearing,
- •or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.
排除标准
- •Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria.
- •Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.
- •Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
- •Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5).
- •Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).
- •Subjects with clinically significant suicidal or homicidal ideation.
- •Subjects with current psychotic symptoms.
- •Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; or a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
- •Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
- •Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests.
- •Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.
- •Women who are pregnant or nursing.
- •Subjects who have received an experimental drug or used an experimental device within 30 days.
- •Subjects who have a history of neuroleptic malignant syndrome.
研究组 & 干预措施
Risperidone
干预措施: Risperidone (Drug)
Sugar pill
干预措施: Risperidone (Drug)
结局指标
主要结局
Clinical Global Improvement-21 Anxiety scale (CGI-21 Anxiety)
时间窗: weekly
次要结局
- Hamilton Anxiety scale (HAM-A)(weekly)