A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder
概览
- 阶段
- 4 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Bipolar Disorder
- 发起方
- VA Palo Alto Health Care System
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- Clinician Global Improvement Scale (CGI-21)
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
详细描述
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 50 subjects will be randomized. Subjects will be randomized to ziprasidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of EPS. 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.
研究者
patricia suppes
Director, Bipolar and Depression Research Program
VA Palo Alto Health Care System
入排标准
入选标准
- •Subjects must be at least 18 and not older than
- •Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria (26).
- •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 moderate in severity, defined as a CGI-BP\< 4 (27).
- •Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S \> 4 (28).
- •Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least 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 criteria (26).
- •Subjects who do not have lifetime panic disorder or GAD by DSM-IV-TR criteria (26).
- •Subjects who are receiving treatment with an anti-manic 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) (27).
- •Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S \< 3) (28).
- •Subjects with clinically significant suicidal or homicidal ideation.
- •Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
- •Subjects with serious general medical illnesses 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 pre-study physical exam, vital signs, EKG, or laboratory tests.
- •Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to ziprasidone.
研究组 & 干预措施
Placebo
Administered in capsules identical to the ziprasidone capsules.
干预措施: Placebo
ziprasidone
Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day.
干预措施: Ziprasidone
结局指标
主要结局
Clinician Global Improvement Scale (CGI-21)
时间窗: 8 weeks
CGI-21 Anxiety Scale ranges from -10 (Very Bad. Could not be worse) to +10 (Major Improvement. Back to normal self).
次要结局
- Hamilton Anxiety Rating Scale (HAM-A)(8 weeks)
- Young Mania Rating Scale(8 weeks)
- Montgomery-Asberg Depression Rating Scale (MADRS)(8 weeks)
- CGI-BP(8 weeks)
- Sheehan Disability Scale (SDS)(8 weeks)
- Sheehan Irritability Scale (SIS)(8 Weeks)