SchizophreniaPhase 2NCT07122895
Sex Differences in NMDA-enhancing Treatment of Schizophrenia
A Phase 2 study testing NMDAE in people with Schizophrenia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms are the core pathology of this disease. NMDA receptor (NMDAR) dysfunction is a key factor in negative symptoms. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- 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
- 16 Sep 2025to Mar 2030
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia
- keep stable mentally for ≥ 6 months before baseline and meet the following clinical criteria: predominantly negative symptoms for ≥ 6 months, a minimum baseline total score of 40 on the SANS, a minimum baseline score of 24 on the negative subscale of the PANSS, and a maximum score of 3 on each item of PANSS-positive subscale;
- Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
- Have been keeping a fixed dose of antipsychotics for at least 6 months, and that is not allowed to change during the 12-week study period
- Have sufficient education to communicate effectively and are capable of completing the assessments of the study
- Agree to participate in the study and provide written informed consent
Who cannot join
- DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
- History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
- Clinically evident depressive symptoms or a baseline score>7 on the Hamilton Depression Rating Scale-17 items
- Clinically relevant parkinsonism or a baseline score >3 on the sum of the first eight items of the Simpson-Angus Scale (SAS)
- 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. 11855, hylane@gmail.com
About this study
Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms are the core pathology of this disease. NMDA receptor (NMDAR) dysfunction is a key factor in negative symptoms. This study aims to examine the sex difference in the efficacy of an NMDA-enhancer (NMDAE) for the treatment of negative symptoms in schizophrenia.
Read the detailed description
Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms, the core pathology of this disease, principally determine the patients' prognoses. NMDAR dysfunction is a key factor in negative symptoms. Whether NMDAR-enhancing treatment can improve negative symptoms and whether there is sex difference need to be studied. The subjects are the schizophrenia patients with predominantly negative symptoms. They will continue their original treatment and be double-blindly, randomly assigned to receive 12-week: (1) NMDAE (N = 60), or (2) placebo (N = 30). There will be half men and half women in each group. We will measure clinical manifestations and side effects at weeks 0, 4, 8, and 12 using Scale for Assessment of Negative Symptoms (the primary outcome), Positive and Negative Syndrome Scale-negative subscale, Clinical Global Impression, Quality of Life Scale, Global Assessment of Function, and scale of side effects. At week 0 and week 12, we will assess 7 cognitive domains. 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
- Schizophrenia
- Being tested
- NMDAE, Placebo Cap
- Keywords
- Schizophrenia, NMDA, Negative symptoms, Sex difference
- Medical subject headings
- Schizophrenia
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 negative symptoms
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 of scales for the Assessment of Negative Symptoms (SANS) total score
Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.
Measured: week 0, 4, 8, 12
Secondary outcomes (5)
Change of Negative subscale of PANSS
Assessment of negative symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome.
Measured: week 0, 4, 8, 12
Change of Clinical Global Impression
Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.
Measured: Frame: week 0, 4, 8, 12
Change of Global Assessment of Functioning composite
Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function.
Measured: week 0, 4, 8, 12
Change of Quality of Life Scale
Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome.
Measured: week 0, 4, 8, 12
Change of cognitive function composite
Ten tests for assessment of 7 cognitive domains:
- speed of processing (assessed by Category Fluency, Trail Marking A, WAIS-III Digit Symbol-Coding)
- sustained attention (Continuous Performance Test)
- working memory: verbal (digit span) and nonverbal (spatial span)
- verbal learning and memory (WMS-III, word listing)
- visual learning and memory (WMS-III, visual reproduction)
- reasoning and problem solving (WISC-III, Maze)
- social cognition (MSCEIT) For the domain (a. and c.) with more than one test, a composite T score will be calculated by standardizing the average of each T score. Furthermore, a global composite score (for all seven domains) and a neurocognitive composite score (for the first 6 domains) will be also calculated by standardizing the average of the T score of each domain (Lane HY et al, JAMA Psychiatry 2013)
Measured: Week 0, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start16 Sep 2025
- Primary completionDec 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122895
- Sponsor's protocol ID
- CMUH114-REC3-042
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in NMDA-enhancing Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT07122895
- Acronym / sponsor ID
- CMUH114-REC3-042
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, NMDA, Negative symptoms, Sex difference
- 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, Taiwan
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 14 Aug 2025 (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.
Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms are the core pathology of this disease. NMDA receptor (NMDAR) dysfunction is a key factor in negative symptoms. This study aims to examine the sex difference in the efficacy of an NMDA-enhancer (NMDAE) for the treatment of negative symptoms in schizophrenia.
Detailed description
Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms, the core pathology of this disease, principally determine the patients' prognoses. NMDAR dysfunction is a key factor in negative symptoms. Whether NMDAR-enhancing treatment can improve negative symptoms and whether there is sex difference need to be studied. The subjects are the schizophrenia patients with predominantly negative symptoms. They will continue their original treatment and be double-blindly, randomly assigned to receive 12-week: (1) NMDAE (N = 60), or (2) placebo (N = 30). There will be half men and half women in each group. We will measure clinical manifestations and side effects at weeks 0, 4, 8, and 12 using Scale for Assessment of Negative Symptoms (the primary outcome), Positive and Negative Syndrome Scale-negative subscale, Clinical Global Impression, Quality of Life Scale, Global Assessment of Function, and scale of side effects. At week 0 and week 12, we will assess 7 cognitive domains. 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
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia
- keep stable mentally for ≥ 6 months before baseline and meet the following clinical criteria: predominantly negative symptoms for ≥ 6 months, a minimum baseline total score of 40 on the SANS, a minimum baseline score of 24 on the negative subscale of the PANSS, and a maximum score of 3 on each item of PANSS-positive subscale;
- Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
- Have been keeping a fixed dose of antipsychotics for at least 6 months, and that is not allowed to change during the 12-week study period
- Have sufficient education to communicate effectively and are capable of completing the assessments of the study
Key exclusion criteria (6 listed)
- DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
- History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
- Clinically evident depressive symptoms or a baseline score>7 on the Hamilton Depression Rating Scale-17 items
- Clinically relevant parkinsonism or a baseline score >3 on the sum of the first eight items of the Simpson-Angus Scale (SAS)
- Pregnancy or lactation
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 negative symptoms | Drug | NMDAE |
| Placebo CapUse of placebo as a comparator | Drug | Placebo |
Primary outcome
Change of scales for the Assessment of Negative Symptoms (SANS) total score
Time frame: week 0, 4, 8, 12
Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.
5 secondary outcomes
Change of Negative subscale of PANSS
Time frame: week 0, 4, 8, 12
Change of Clinical Global Impression
Time frame: Frame: week 0, 4, 8, 12
Change of Global Assessment of Functioning composite
Time frame: week 0, 4, 8, 12
Change of Quality of Life Scale
Time frame: week 0, 4, 8, 12
Change of cognitive function composite
Time frame: Week 0, 12
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 17 Sep 2025.
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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 Schizophrenia, 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 6 inclusion and 6 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 17 Sep 2025. 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, M.D., Ph.D (886 4 22052121 ext. 11855, hylane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of scales for the Assessment of Negative Symptoms (SANS) total score (time frame: week 0, 4, 8, 12). 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 17 Sep 2025.