Memantine Augmentation of Targeted Cognitive Training in Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Positive & Negative Symptom Scale total (PANSSt)
研究概览
简要总结
Treatment of schizophrenia currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.
详细描述
Treatment of schizophrenia (SZ) currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of targeted cognitive training (TCT) in schizophrenia. This project tests a rational and empirically supported platform for augmenting the benefits of TCT in antipsychotic medicated SZ patients by adjunctive daily treatment of 20 mg memantine, an FDA approved medication for the treatment of cognitive dysfunction in Alzheimer's Disease. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of 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
- Double (Participant, Investigator)
盲法说明
Subjects will be randomized to TCT and memantine or TCT and placebo. The research will be provided with a randomization scheme to follow and will dispense the pills identified only by a code.
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
- •DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- •Written informed consent to participate in the study
- •Age 18-65
- •Absence of dementia or mental retardation
- •Urine toxicology negative for recreational drugs
- •Fluent and literate in English
排除标准
- •Meets DSM-IV criteria for current substance abuse or dependence and has been substance abstinent for less than 30 days
- •A history of traumatic brain injury
- •Auditory or visual impairments severe enough to prevent study participation
- •Under conservatorship (determined by Anasazi)
- •Pregnancy
研究组 & 干预措施
TCT + MEM
Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
干预措施: Memantine (Drug)
TCT + PBO
Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
干预措施: Placebo (Drug)
结局指标
主要结局
Positive & Negative Symptom Scale total (PANSSt)
时间窗: approximately 13 weeks
PANSS Total Score is the primary clinical outcome measured at baseline vs. post TCT session 10, 20 and 30 (approximately 13 weeks). The PANSS total score has a range 30-210, with higher scores indicating worse outcome.
World Health Organization Disability Schedule (WHODAS 2.0)
时间窗: approximately 13 weeks
Function will be assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline vs. post-TCT session 10, 20 and 30 (approximately 13 weeks). The World Health Organization Disability Schedule (WHODAS 2.0) has a range 12-60, with higher scores indicating worse outcome.
MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C)
时间窗: approximately 13 weeks
The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 13 weeks). The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores, which are standardized based on a community sample. A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome.
次要结局
- Positive & Negative Symptom Scale (PANSS) - positive symptom subscale(approximately 13 weeks)
- Positive & Negative Symptom Scale (PANSS) - negative symptom subscale(approximately 13 weeks)
- Psychotic Symptoms - PSYRATS hallucination subscale(approximately 13 weeks)
- Manic Symptoms - Young Mania Rating Scale(approximately 13 weeks)
- Current Depressive Symptoms - PHQ-9(approximately 13 weeks)
研究者
Gregory Light
Professor
University of California, San Diego