NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NMDAE, Placebo Cap.
- Who it may be relevant to
- Registry conditions: Bipolar I Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
Overview
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.
Detailed description
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.
Interventions
- Drug NMDAE
Use of an NMDA enhancer for the treatment of bipolar depression - Drug Placebo Cap
Use of placebo as a comparator.
Primary outcome measures
- Change in Visual Continuous Performance Test [Time frame: week 0, 8]
- Change in Wisconsin Card Sorting Test [Time frame: week 0, 8]
- Change in Logical Memory Test of the Wechsler Memory Scale [Time frame: week 0, 8]
- Digit Span [Time frame: week 0, 8]
- Spatial Span [Time frame: week 0, 8]
- Category Fluency [Time frame: week 0, 8]
- Trail Marking A [Time frame: week 0, 8]
- WAIS-III Digit Symbol-Coding [Time frame: week 0, 8]
- Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0 [Time frame: week 0, 8]
- Change in Perceived Stress Scale in Perceived Stress Scale [Time frame: week 0, 2, 4, 6, 8]
Secondary outcome measures (7)
- Change in Quality of life (SF-36) [Time frame: week 0, 8]
- Change in Global Assessmeint of Functioning [Time frame: Week 0, 2, 4, 6, 8]
- Change in Hamilton Rating Scale for Depression [Time frame: Week 0, 2, 4, 6, 8]
- Change in Montgomery-Åsberg Depression Rating Scale [Time frame: Week 0, 2, 4, 6, 8]
- Change in Young Mania Rating Scale [Time frame: Week 0, 2, 4, 6, 8]
- Change in Beck Scale for Suicide Ideation [Time frame: Week 0, 2, 4, 6, 8]
- Change in Clinical Global Impression Scale [Time frame: Week 0, 2, 4, 6, 8]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Department of Psychiatry, China Medical University Hospital — Taichung
Identifiers
NCT: NCT05977023 · CMUH111-REC2-222