NCT05977023 NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
| NCT ID | NCT05977023 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | China Medical University Hospital |
| Condition | Bipolar I Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-10-04 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2023-10-04 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05977023 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar I Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05977023 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05977023 currently recruiting?
Yes, NCT05977023 is actively recruiting participants. Contact the research team at hylane@gmail.com for enrollment information.
Where is the NCT05977023 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT05977023 clinical trial?
NCT05977023 is sponsored by China Medical University Hospital. The trial plans to enroll 90 participants.
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