NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Logical Memory Test of the Wechsler Memory Scale
研究概览
简要总结
At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.
详细描述
Bipolar I disorder (BD-I) is a severe brain disorder. At present, the treatment of BD-I, especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.
The subjects are bipolar depression patients. They have been treated for bipolar depression for at least four weeks but remain depressive. Participating in this study, they will continue the original treatment, and will be randomized, double-blindly to receive the NMDAE or placebo for 8 weeks. We will measure 6 cognitive domains (including 9 cognitive tests) and quality of life at weeks 0 and 8; and assess the Perceived Stress Scale, Global Assessment of Function (GAF), various scales for clinical symptoms, and side effects at weeks 0, 2, 4, 6, and 8.
The efficacies of NMDAE and placebo will be compared. Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.
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
- •Are 18 to 65 years of age;
- •Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, current episode depressed, after treatment of stable (i.e., at least 4 weeks) and adequate treatment of antipsychotic (quetiapine or lurasidone) and/or mood stabilizer;
- •Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young Mania Rating Scale (YMRS) score ≤7 at baseline;
- •Agree to participate in the study and provide informed consent
排除标准
- •Current substance abuse or history of substance dependence in the past 6 months
- •History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
- •Schizophrenia or other psychotic disorder
- •Moderate-severe suicidal risks
- •Severe cognitive impairment
- •Clinically significant laboratory screening tests (including blood routine, biochemical tests)
- •Pregnancy or lactation;
- •Inability to follow protocol
研究组 & 干预措施
NMDAE
An NMDA enhancer
干预措施: NMDAE (Drug)
Placebo
Placebo
干预措施: Placebo Cap (Drug)
结局指标
主要结局
Change in Logical Memory Test of the Wechsler Memory Scale
时间窗: week 0, 8
Assessment of episodic memory
Spatial Span
时间窗: week 0, 8
Assessment of nonverbal working memory
Change in Perceived Stress Scale in Perceived Stress Scale
时间窗: week 0, 2, 4, 6, 8
Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0
时间窗: week 0, 8
Assessment of social cognition
Change in Wisconsin Card Sorting Test
时间窗: week 0, 8
Assessment of abstract and shift set
Digit Span
时间窗: week 0, 8
Assessment of verbal working memory
Change in Visual Continuous Performance Test
时间窗: week 0, 8
Assessment of sustained attention
Trail Marking A
时间窗: week 0, 8
Assessment of speed of processing
WAIS-III Digit Symbol-Coding
时间窗: week 0, 8
Assessment of speed of processing
Category Fluency
时间窗: week 0, 8
Assessment of speed of processing
次要结局
- Change in Hamilton Rating Scale for Depression(Week 0, 2, 4, 6, 8)
- Change in Clinical Global Impression Scale(Week 0, 2, 4, 6, 8)
- Change in Quality of life (SF-36)(week 0, 8)
- Change in Global Assessmeint of Functioning(Week 0, 2, 4, 6, 8)
- Change in Montgomery-Åsberg Depression Rating Scale(Week 0, 2, 4, 6, 8)
- Change in Beck Scale for Suicide Ideation(Week 0, 2, 4, 6, 8)
- Change in Young Mania Rating Scale(Week 0, 2, 4, 6, 8)