NCT05977023

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Oct 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

July 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

July 28, 2023

Last Update Submit

February 16, 2025

Conditions

Bipolar I Disorder

Keywords

Bipolar I disorderBipolar depressionNMDA

Outcome Measures

Primary Outcomes (10)

  • Change in Visual Continuous Performance Test

    Assessment of sustained attention

    week 0, 8

  • Change in Wisconsin Card Sorting Test

    Assessment of abstract and shift set

    week 0, 8

  • Change in Logical Memory Test of the Wechsler Memory Scale

    Assessment of episodic memory

    week 0, 8

  • Digit Span

    Assessment of verbal working memory

    week 0, 8

  • Spatial Span

    Assessment of nonverbal working memory

    week 0, 8

  • Category Fluency

    Assessment of speed of processing

    week 0, 8

  • Trail Marking A

    Assessment of speed of processing

    week 0, 8

  • WAIS-III Digit Symbol-Coding

    Assessment of speed of processing

    week 0, 8

  • Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0

    Assessment of social cognition

    week 0, 8

  • 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 Outcomes (7)

  • Change in Quality of life (SF-36)

    week 0, 8

  • Change in Global Assessmeint of Functioning

    Week 0, 2, 4, 6, 8

  • Change in Hamilton Rating Scale for Depression

    Week 0, 2, 4, 6, 8

  • Change in Montgomery-Åsberg Depression Rating Scale

    Week 0, 2, 4, 6, 8

  • Change in Young Mania Rating Scale

    Week 0, 2, 4, 6, 8

  • +2 more secondary outcomes

Study Arms (2)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDAE

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Cap

Interventions

NMDAEDRUG

Use of an NMDA enhancer for the treatment of bipolar depression

NMDAE
Placebo CapDRUG

Use of placebo as a comparator.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

Hsien-Yuan Lane Lane, M.D., Ph.D

CONTACT

886 4 22052121hylane@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 4, 2023

Study Start

October 4, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

TW(1)