NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Recruiting · NCT05977023 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
NMDAEPlacebo Cap
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Department of Psychiatry, China Medical University Hospital - Taichung, Taiwan