Prodromal SchizophreniaPhase 2NCT05052853
Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
A Phase 2 study testing NMDAE in people with Prodromal Schizophrenia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study. Read more about this study
- Who is it for?
- Ages 13 to 45 years
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- NMDAE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to Dec 2026
- 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 13 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration).
- Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms [SOPS] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period.
- Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period.
- Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject < 20 years old, a parent also has to provide written informed consent.
Who cannot join
- DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition.
- History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study.
- 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
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.
Read the detailed description
Several lines of evidence suggest that NMDA hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to benefit the treatment of schizophrenia. Whether an NMDA-enhancer (NMDAE) can benefit the treatment of prodromal schizophrenia deserves study. Therefore, this study aims to compare NMDAE and placebo in the treatment of prodromal schizophrenia.
The subjects with prodromal schizophrenia at first receive 6 weeks of health-promotion intervention (including exercise and education). A total of 48 subjects who do not respond sufficiently to the health-promotion program are then recruited to this 12-week, randomized, double-blind, placebo-controlled trial, which aims to compare treatment response of NMDAE vs. placebo in 1:1 ratio. Clinical performances and side effects are measured at weeks -6 (before the screening phase), 0 (baseline of the drug trial), 2, 4, 6, 9, and 12. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests.
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
- Prodromal Schizophrenia
- Being tested
- NMDAE, Placebo Cap
- Keywords
- Schizophrenia, Prodrome, NMDA
- Medical subject headings
- Schizotypal Personality Disorder, 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 prodromal schizophrenia .
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 from baseline in Scale of Prodromal Symptoms [SOPS] total score
Assessment of overall prodromal symptoms. Minimum value: 0, maximum value: 114, the higher scores mean a worse outcome.
As shown in "Detailed Description", "mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). That is, GEE is used for analyzing the changes from baseline in repeated-measure assessments by a single analysis (but not multiple analyses).
Measured: week 0, 2, 4, 6, 9, 12
Secondary outcomes (10)
Change from baseline in SOPS Positive Symptom Scale score
Assessment of positive prodromal symptoms. Minimum value: 0, maximum value: 30, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in SOPS Negative Symptom Scale score
Assessment of negative prodromal symptoms. Minimum value: 0, maximum value: 36, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in SOPS Disorganization Symptom Scale score
Assessment of disorganization prodromal symptoms. Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in SOPS General Symptom Scale score
Assessment of general prodromal symptoms. Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in Scales for the Assessment of Negative Symptoms (SANS) total score
Assessment of schizophrenia negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in Clinical Global Impression
Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in Global Assessment of Functioning
Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline 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, 9, 12
Change from baseline in Quality of Life Scale
Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome.
Measured: week 0, 2, 4, 6, 9, 12
Change from baseline in Cognitive function
The measure is the composite from multiple measures. All tests have no unit. 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, a-f) will be also calculated by standardizing the average of the T score of each domain (Lane HY et al, JAMA Psychiatry. 2013).
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 Version 2)
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 posted22 Sep 2021
- Study start1 Nov 2021
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052853
- Sponsor's protocol ID
- CMUH110-REC3-114
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2021
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
- ClinicalTrials.gov ID
- NCT05052853
- Acronym / sponsor ID
- CMUH110-REC3-114
- Conditions
- Prodromal Schizophrenia
- Keywords
- Schizophrenia, Prodrome, NMDA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Sep 2021 (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.
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.
Detailed description
Several lines of evidence suggest that NMDA hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to benefit the treatment of schizophrenia. Whether an NMDA-enhancer (NMDAE) can benefit the treatment of prodromal schizophrenia deserves study. Therefore, this study aims to compare NMDAE and placebo in the treatment of prodromal schizophrenia.
The subjects with prodromal schizophrenia at first receive 6 weeks of health-promotion intervention (including exercise and education). A total of 48 subjects who do not respond sufficiently to the health-promotion program are then recruited to this 12-week, randomized, double-blind, placebo-controlled trial, which aims to compare treatment response of NMDAE vs. placebo in 1:1 ratio. Clinical performances and side effects are measured at weeks -6 (before the screening phase), 0 (baseline of the drug trial), 2, 4, 6, 9, and 12. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests.
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
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration).
- Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms [SOPS] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period.
- Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period.
- Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject < 20 years old, a parent also has to provide written informed consent.
Key exclusion criteria (5 listed)
- DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition.
- History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study.
- Clinically significant laboratory screening tests (including blood routine, biochemical tests)
- Pregnancy or lactation
- Inability to follow protocol
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 prodromal schizophrenia . | Drug | NMDAE |
| Placebo CapUse of placebo as a comparator | Drug | Placebo |
Primary outcome
Change from baseline in Scale of Prodromal Symptoms [SOPS] total score
Time frame: week 0, 2, 4, 6, 9, 12
Assessment of overall prodromal symptoms. Minimum value: 0, maximum value: 114, the higher scores mean a worse outcome. As shown in "Detailed Description", "mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). That is, GEE is used for analyzing the changes from baseline in repeated-measure assessments by a single analysis (but not multiple analyses).
10 secondary outcomes
Change from baseline in SOPS Positive Symptom Scale score
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in SOPS Negative Symptom Scale score
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in SOPS Disorganization Symptom Scale score
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in SOPS General Symptom Scale score
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in Scales for the Assessment of Negative Symptoms (SANS) total score
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in Clinical Global Impression
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in Global Assessment of Functioning
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in Hamilton Rating Scale for Depression
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in Quality of Life Scale
Time frame: week 0, 2, 4, 6, 9, 12
Change from baseline in Cognitive function
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 24 Mar 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 Prodromal 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 4 inclusion and 5 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 24 Mar 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, 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 from baseline in Scale of Prodromal Symptoms [SOPS] total score (time frame: week 0, 2, 4, 6, 9, 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 24 Mar 2026.