NCT05977023RecruitingPhase 2
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 28 Jul 2023
- Start date
- 4 Oct 2023
- Primary completion date
- Nov 2027
- Lead sponsor
- China Medical University Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT05977023
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 4 Oct 2023 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Severe cognitive impairment
Lab values
- Clinically significant laboratory screening tests (including blood routine, biochemical tests)
Other
- Moderate-severe suicidal risks
- Pregnancy or lactation;
- Inability to follow protocol
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.