Changes in Cognitive Functioning in Euthymic Bipolar Patients Treated With Lurasidone Versus Treatment as Usual; A Randomized, Open-Label Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Cognitive Change in Bipolar I disorder after treatment with Lurasidone
研究概览
简要总结
This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I disorder (manic depression), who are in remission from an episode. Participants who show cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on to their current medication(s) or continue their usual treatment for 6 weeks. Participants will have 3 clinical visits and 2 telephone appointments during the study. Given the preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.
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
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization.
- •Patients who show cognitive impairments (-0.25 standard deviations (SD) or below) on either the Trail Making Test- trial B (TMT-B) or California Verbal Learning Test (CVLT) trials 1 to 5, or CVLT long delay free recall, at baseline visit.
- •Males or females aged 19 to 65 years inclusive.
- •Diagnostic and Statistical Manual IV edition (DSM-IV TR) diagnosis of Bipolar Type I Disorder, with or without a history of psychosis.
- •Clinically stable with a Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to
- •A sufficient level of English using a language screening questionnaire.
- •Capability of understanding, consenting to, and complying with the requirements of the study.
排除标准
- •A history of unstable or inadequately treated medical illnesses, including moderate to severe brain injury, or neurological illnesses impacting cognitive function.
- •Treatment with Electroconvulsive Therapy (ECT) within eight weeks prior to enrolment; or treatment with an experimental drug within 30 days prior to enrolment.
- •Axis I diagnosis of substance abuse or dependence within the past month.
- •Significant risk of harm to self or others, in the opinion of the investigator.
- •Pregnancy or lactation in female subjects.
- •Liver function tests (AST and ALT) three times the upper limit of normal. -
研究组 & 干预措施
Lurasidone
Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
干预措施: Lurasidone (Drug)
结局指标
主要结局
Cognitive Change in Bipolar I disorder after treatment with Lurasidone
时间窗: 6 weeks
The International Society for Bipolar Disorders-Battery for Assessment of Neurocognition (ISBD-BANC) will be administered to assess cognitive functioning at baseline and at endpoint ( change in scores on cognitive tests) to evaluate the efficacy of lurasidone on cognitive changes in bipolar disorder.
次要结局
未报告次要终点