NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
ConditionBipolar I Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NMDAE
- Placebo Cap
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
China Medical University Hospital
Lead sponsor
National Science and Technology Council
Collaborator
Source ClinicalTrials.gov