NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Department of Psychiatry, China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Hsien-Yuan Lane Lane, M.D., Ph.D
hylane@gmail.com
886 4 22052121
Time Frame
Start Date: 2023-10-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 90
Treatments
Experimental: NMDAE
An NMDA enhancer
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Science and Technology Council
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov