Pramipexole in Bipolar Disorder: Targeting Cognition (PRAM-BD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- MATRICS Consensus Cognitive Battery
研究概览
简要总结
Converging evidence suggests that patients with bipolar disorder suffer from deficits in neurocognitive functioning that persist, despite remission of acute affective symptoms. These impairments contribute directly to functional disability, highlighting the need for interventions above and beyond standard treatments in order to achieve a full inter-episode recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using a placebo-controlled, adjunctive, 12-week trial design.
详细描述
All eligible participants will undergo study visits at screening, baseline (week 0), week 1, week 2, week 3, week 4, week 6, week 8, and week 12, (end of study).
Randomization will be conducted via a computer generated program and all study staff will be blinded unless un-blinding is required for safety reasons. Subjects will be randomized on a 1:1 ratio with stratification for concomitant antipsychotic status and depression at baseline (HRSD <8 vs > 8). Study drug will be blinded and matched to placebo. Adapting from our previous work in BD and according to package labeling, the dosage titration schedule will be slow and flexible. Dosing will be initiated at 0.25 mg QHS on night one, followed by 0.25 mg BID day two onward, and increased every week to a target of 4.5 mg/day. As compared with our previous maximum 1.5 mg/day (Burdick et al. 2012), we opted to allow up to 4.5 mg/day (the maximum approved dosage in Parkinson's disease) to ensure adequate target engagement. We are familiar with this dose range, as 4.5 mg/day was allowed in our study in BD depression (Goldberg et al. 2004). Dosing will be flexible based on side effects; however, if 1.5 mg/day cannot be tolerated, the subject will be discontinued. Titration will occur up to week 6 and then efforts will be made to maintain the same dose until the completion of the trial (week 12).
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, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •History of CNS trauma, neurological disorder, ADHD, or learning disability
- •Positive urine toxicology or DSM-IV diagnosis of substance abuse/dependence within 3 months
- •Active, unstable medical problem that may interfere with cognition
- •Recent history of rapid-cycling
- •Abnormal lab or ECG result at screen
- •History of heart failure
- •Significant suicidal risk (HRSD item 3 > 2 or by clinical judgment)
- •Estimated IQ in MR range as per Wide Range Achievement Test (WRAT) standard score of less than 70
- •Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (including oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
- •Women who are breastfeeding
- •Participation in any other investigational cognitive enhancement study within 30 days
研究组 & 干预措施
Pramipexole
Pramipexole, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.
干预措施: Pramipexole (Drug)
Placebo
Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
MATRICS Consensus Cognitive Battery
时间窗: Week 12
MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.
次要结局
- Young Mania Rating Scale (YMRS)(Baseline and week 12)
- Hamilton Rating Scale for Depression (HRSD)(Baseline and week 12)
- Number of Participants With Suicidal Acknowledgements(up to Week 12)
- Brief Psychiatric Rating Scale (BPRS)(Baseline and week 12)
- The Probabilistic Stimulus Selection Task(Week 12)
研究者
Katherine Burdick
Lead Investigator
Brigham and Women's Hospital