NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977023
• Other study ID #: CMUH111-REC2-222
• Status: Recruiting
• Phase: Phase 2
• Start date: October 4, 2023
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: China Medical University Hospital
• Contact: Hsien-Yuan Lane Lane, M.D., Ph.D
• Phone: 886 4 22052121
• Email: hylane[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Bipolar I disorder (BD-I) is a severe brain disorder. At present, the treatment of 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. 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.

The subjects are bipolar depression patients. They have been treated for bipolar depression for at least four weeks but remain depressive. Participating in this study, they will continue the original treatment, and will be randomized, double-blindly to receive the NMDAE or placebo for 8 weeks. We will measure 6 cognitive domains (including 9 cognitive tests) and quality of life at weeks 0 and 8; and assess the Perceived Stress Scale, Global Assessment of Function (GAF), various scales for clinical symptoms, and side effects at weeks 0, 2, 4, 6, and 8.

The efficacies of NMDAE and placebo will be compared. Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• NMDAE
Use of an NMDA enhancer for the treatment of bipolar depression
• Placebo Cap
Use of placebo as a comparator.

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Continuous Performance Test	Assessment of sustained attention	week 0, 8
Primary	Change in Wisconsin Card Sorting Test	Assessment of abstract and shift set	week 0, 8
Primary	Change in Logical Memory Test of the Wechsler Memory Scale	Assessment of episodic memory	week 0, 8
Primary	Digit Span	Assessment of verbal working memory	week 0, 8
Primary	Spatial Span	Assessment of nonverbal working memory	week 0, 8
Primary	Category Fluency	Assessment of speed of processing	week 0, 8
Primary	Trail Marking A	Assessment of speed of processing	week 0, 8
Primary	WAIS-III Digit Symbol-Coding	Assessment of speed of processing	week 0, 8
Primary	Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0	Assessment of social cognition	week 0, 8
Primary	Change in Perceived Stress Scale in Perceived Stress Scale	Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.	week 0, 2, 4, 6, 8
Secondary	Change in Quality of life (SF-36)		week 0, 8
Secondary	Change in Global Assessmeint of Functioning	Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.	Week 0, 2, 4, 6, 8
Secondary	Change in Hamilton Rating Scale for Depression	Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.	Week 0, 2, 4, 6, 8
Secondary	Change in Montgomery-Åsberg Depression Rating Scale	Assessment of depressive symptoms. Minimum value: 0, maximum value:60, the higher scores mean a worse outcome.	Week 0, 2, 4, 6, 8
Secondary	Change in Young Mania Rating Scale	Assessment of manic symptoms. Minimum value: 0, maximum value:60, the higher scores mean a worse outcome.	Week 0, 2, 4, 6, 8
Secondary	Change in Beck Scale for Suicide Ideation	Assessment of Suicide Ideation. Minimum value: 0, maximum value:38, the higher scores mean a greater risk of suicide.	Week 0, 2, 4, 6, 8
Secondary	Change in Clinical Global Impression Scale		Week 0, 2, 4, 6, 8