A Randomized, Rater-Blind, Controlled, Clinical Trial of Conversion to Antipsychotic Monotherapy vs. Continued Polypharmacy for Patients With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 主要终点
- Positive and Negative Symptom Scale (PANSS) total score
研究概览
简要总结
This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to determine whether patients with chronic schizophrenia or schizoaffective disorder receiving two different antipsychotics simultaneously will have any significant change in psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests.
The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the regular in-patient units of RPC and transferred to the CREF. Following baseline assessments, patients will be randomized to continued antipsychotic polypharmacy treatment or to systematic conversion to monotherapy.
Conversion to antipsychotic monotherapy will be assessed across multiple domains of psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome measure is PANSS total score. The secondary outcome measure is time on medication (all-cause dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to antipsychotic monotherapy will show minimal change from the control group.
详细描述
Background:
Often, treatment resistant schizophrenia patients are treated with high doses of, or polypharmacy with, antipsychotics, or both. There is a lack of systematic evidence for either practice, and this is not recommended by most treatment guidelines. Often polypharmacy results in dosages well above the recommended upper limit of dosage. Recent studies of antipsychotic utilization, have reported that approximately 10-60% of patients are prescribed at least two antipsychotics.
Moreover, antipsychotic treatment carries substantial risks, including the potential development of tardive dyskinesia or metabolic syndrome. Higher doses may expose patients to more adverse events or consequences without any additional therapeutic benefit. Clear benefits of long-term treatment with antipsychotic polypharmacy have rarely been reported, and there is a void of long term double blind, placebo controlled trials.
Antipsychotic polypharmacy remains common, including patients receiving atypical antipsychotics. To our knowledge, no one has published a study of a systematic, randomized controlled conversion to antipsychotic monotherapy for patients with chronic schizophrenia or schizoaffective disorder receiving atypical antipsychotic polypharmacy.
Design:
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
- Single (Outcomes Assessor)
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
- •Patients aged 18-64 with a SCID DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder, confirmed by SCID, who are able to give written informed consent and on stable dosages of two antipsychotics for at least one month prior to baseline.
排除标准
- •Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team)
- •unstable medical illness
- •use of long acting injectable preparations of antipsychotic medication in the previous two months
- •documented failure of previous dose reduction
- •current treatment with clozapine
- •addition of any new psychotropic in the previous month
- •patients who are severely assaultive and in clinical need of more than one antipsychotic for their safe management
结局指标
主要结局
Positive and Negative Symptom Scale (PANSS) total score
时间窗: 12 weeks
Relapse Rate
时间窗: 12 weeks
次要结局
- Nurses Observation Scale for Inpatient Evaluation (NOSIE)(12 weeks)
- Abnormal Involuntary Movement Scale (AIMS)(12 weeks)
- Weight(12 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(12 weeks)
- Simpson-Angus Scale (SAS)(12 weeks)
- Barnes Akathisia Scale(12 weeks)
- MATRICS(12 weeks)
- Clinical Global Impression (CGI)(12 weeks)