Using NMDA receptor modulation to treat cognitive impairment in bipolar I disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.