NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

Официальное название

NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат NMDAE
  Use of an NMDA enhancer for the treatment of bipolar depression
• Препарат Placebo Cap
  Use of placebo as a comparator.

Первичные конечные точки

• Change in Visual Continuous Performance Test [Срок оценки: week 0, 8]
• Change in Wisconsin Card Sorting Test [Срок оценки: week 0, 8]
• Change in Logical Memory Test of the Wechsler Memory Scale [Срок оценки: week 0, 8]
• Digit Span [Срок оценки: week 0, 8]
• Spatial Span [Срок оценки: week 0, 8]
• Category Fluency [Срок оценки: week 0, 8]
• Trail Marking A [Срок оценки: week 0, 8]
• WAIS-III Digit Symbol-Coding [Срок оценки: week 0, 8]
• Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0 [Срок оценки: week 0, 8]
• Change in Perceived Stress Scale in Perceived Stress Scale [Срок оценки: week 0, 2, 4, 6, 8]

Вторичные конечные точки (7)

• Change in Quality of life (SF-36) [Срок оценки: week 0, 8]
• Change in Global Assessmeint of Functioning [Срок оценки: Week 0, 2, 4, 6, 8]
• Change in Hamilton Rating Scale for Depression [Срок оценки: Week 0, 2, 4, 6, 8]
• Change in Montgomery-Åsberg Depression Rating Scale [Срок оценки: Week 0, 2, 4, 6, 8]
• Change in Young Mania Rating Scale [Срок оценки: Week 0, 2, 4, 6, 8]
• Change in Beck Scale for Suicide Ideation [Срок оценки: Week 0, 2, 4, 6, 8]
• Change in Clinical Global Impression Scale [Срок оценки: Week 0, 2, 4, 6, 8]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Department of Psychiatry, China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT05977023 · CMUH111-REC2-222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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