Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
NCT ID: NCT05052853
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2021-11-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NMDAE
An NMDA enhancer
NMDAE
Use of an NMDA enhancer for the treatment of prodromal schizophrenia .
Placebo
Placebo
Placebo Cap
Use of placebo as a comparator
Interventions
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NMDAE
Use of an NMDA enhancer for the treatment of prodromal schizophrenia .
Placebo Cap
Use of placebo as a comparator
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
13 Years
45 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Locations
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Department of Psychiatry, China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH110-REC3-114
Identifier Type: -
Identifier Source: org_study_id
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