Using NMDA receptor modulation to treat cognitive impairment in bipolar I disorder
NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
PHASE2 · China Medical University Hospital · NCT05977023
This study is testing a new treatment to see if it can help improve thinking skills and reduce stress in adults with bipolar I disorder who are having depressive episodes.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | China Medical University Hospital (other) |
| Locations | 1 site (Taichung) |
| Trial ID | NCT05977023 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of an NMDA enhancer (NMDAE) in treating cognitive impairment and perceived stress in patients with bipolar I disorder experiencing depressive episodes. Participants, aged 18 to 65, who have been on stable treatment for at least four weeks, will be randomized to receive either NMDAE or a placebo for eight weeks. The study will assess cognitive function and quality of life through various scales and tests at multiple time points. The results will help determine the effectiveness of NMDAE compared to placebo in improving symptoms associated with bipolar depression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of bipolar I disorder currently experiencing a depressive episode.
Not a fit: Patients with severe cognitive impairment, psychotic disorders, or significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and reduce perceived stress in patients with bipolar I disorder.
How similar studies have performed: While NMDA receptor modulation is a novel approach in this context, similar studies have shown promise in treating cognitive dysfunction in other psychiatric disorders.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taichung
- Department of Psychiatry, China Medical University Hospital — Taichung, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hsien-Yuan Lane Lane, M.D., Ph.D
- Email: hylane@gmail.com
- Phone: 886 4 22052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar I Disorder, Bipolar I disorder, Bipolar depression, NMDA