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NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

RecruitingPhase 2Ages 18 Years - 65 YearsAllChina Medical University Hospital
NCT05977023 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • NMDAE
  • Placebo Cap
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Where

1 site
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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