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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT05977023
- Acronym / sponsor ID
- CMUH111-REC2-222
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I disorder, Bipolar depression, NMDA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMDAE | Experimental | Drug: NMDAEAn NMDA enhancer |
| Placebo | Placebo comparator | Drug: Placebo CapPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMDAEUse of an NMDA enhancer for the treatment of bipolar depression | Drug | NMDAE |
| Placebo CapUse of placebo as a comparator. | Drug | Placebo |
Primary outcome
Change in Visual Continuous Performance Test
Time frame: week 0, 8
Assessment of sustained attention
Change in Wisconsin Card Sorting Test
Time frame: week 0, 8
Assessment of abstract and shift set
Change in Logical Memory Test of the Wechsler Memory Scale
Time frame: week 0, 8
Assessment of episodic memory
Digit Span
Time frame: week 0, 8
Assessment of verbal working memory
Spatial Span
Time frame: week 0, 8
Assessment of nonverbal working memory
Category Fluency
Time frame: week 0, 8
Assessment of speed of processing
Trail Marking A
Time frame: week 0, 8
Assessment of speed of processing
WAIS-III Digit Symbol-Coding
Time frame: week 0, 8
Assessment of speed of processing
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0
Time frame: week 0, 8
Assessment of social cognition
Change in Perceived Stress Scale in Perceived Stress Scale
Time frame: week 0, 2, 4, 6, 8
Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.
7 secondary outcomes
Change in Quality of life (SF-36)
Time frame: week 0, 8
Change in Global Assessmeint of Functioning
Time frame: Week 0, 2, 4, 6, 8
Change in Hamilton Rating Scale for Depression
Time frame: Week 0, 2, 4, 6, 8
Change in Montgomery-Åsberg Depression Rating Scale
Time frame: Week 0, 2, 4, 6, 8
Change in Young Mania Rating Scale
Time frame: Week 0, 2, 4, 6, 8
Change in Beck Scale for Suicide Ideation
Time frame: Week 0, 2, 4, 6, 8
Change in Clinical Global Impression Scale
Time frame: Week 0, 2, 4, 6, 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NMDAE in people with Bipolar I Disorder, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsien-Yuan Lane Lane, M.D., Ph.D (886 4 22052121 ext. 1855, hylane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Continuous Performance Test (time frame: week 0, 8). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.