Bipolar I DisorderPhase 2NCT05977023
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
A Phase 2 study testing NMDAE in people with Bipolar I Disorder, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- NMDAE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2023to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Psychiatry, China Medical University Hospital
Taichung
Hsien-Yuan Lane, M.D., Ph.D, 886 4 22052121 ext. 1855, hylane@gmail.com
About this study
Official title: NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
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.
Read the detailed 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.
- Conditions
- Bipolar I Disorder
- Being tested
- NMDAE, Placebo Cap
- Keywords
- Bipolar I disorder, Bipolar depression, NMDA
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMDAEDrug
Use of an NMDA enhancer for the treatment of bipolar depression
Placebo CapDrug
Use of placebo as a comparator.
| Study group | Role | What they receive |
|---|---|---|
| NMDAE | Experimental | An NMDA enhancer Receives: Drug: NMDAE |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Continuous Performance Test
Assessment of sustained attention
Measured: week 0, 8
Change in Wisconsin Card Sorting Test
Assessment of abstract and shift set
Measured: week 0, 8
Change in Logical Memory Test of the Wechsler Memory Scale
Assessment of episodic memory
Measured: week 0, 8
Digit Span
Assessment of verbal working memory
Measured: week 0, 8
Spatial Span
Assessment of nonverbal working memory
Measured: week 0, 8
Category Fluency
Assessment of speed of processing
Measured: week 0, 8
Trail Marking A
Assessment of speed of processing
Measured: week 0, 8
WAIS-III Digit Symbol-Coding
Assessment of speed of processing
Measured: week 0, 8
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0
Assessment of social cognition
Measured: 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.
Measured: week 0, 2, 4, 6, 8
Secondary outcomes (7)
Change in Quality of life (SF-36)
Measured: week 0, 8
Change in Global Assessmeint of Functioning
Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.
Measured: Week 0, 2, 4, 6, 8
Change in Hamilton Rating Scale for Depression
Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
Measured: Week 0, 2, 4, 6, 8
Change in Montgomery-Åsberg Depression Rating Scale
Assessment of depressive symptoms. Minimum value: 0, maximum value:60, the higher scores mean a worse outcome.
Measured: Week 0, 2, 4, 6, 8
Change in Young Mania Rating Scale
Assessment of manic symptoms. Minimum value: 0, maximum value:60, the higher scores mean a worse outcome.
Measured: Week 0, 2, 4, 6, 8
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.
Measured: Week 0, 2, 4, 6, 8
Change in Clinical Global Impression Scale
Measured: Week 0, 2, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start4 Oct 2023
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977023
- Sponsor's protocol ID
- CMUH111-REC2-222
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No