- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052853
Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Taichung, Taiwan
- Recruiting
- Department of Psychiatry, China Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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Use of placebo as a comparator
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EXPERIMENTAL: NMDAE
An NMDA enhancer
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Use of an NMDA enhancer for the treatment of prodromal schizophrenia .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Scale of Prodromal Symptoms [SOPS] total score
Time Frame: week 0, 2, 4, 6, 9, 12
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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). |
week 0, 2, 4, 6, 9, 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in SOPS Positive Symptom Scale score
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of positive prodromal symptoms.
Minimum value: 0, maximum value: 30, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in SOPS Negative Symptom Scale score
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of negative prodromal symptoms.
Minimum value: 0, maximum value: 36, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in SOPS Disorganization Symptom Scale score
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of disorganization prodromal symptoms.
Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in SOPS General Symptom Scale score
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of general prodromal symptoms.
Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in Scales for the Assessment of Negative Symptoms (SANS) total score
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of schizophrenia negative symptoms.
Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in Clinical Global Impression
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of general impression.
Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in Global Assessment of Functioning
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of social, occupational, and psychological function.
Minimum value: 1, maximum value:100, the higher scores mean better function.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in Hamilton Rating Scale for Depression
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of depressive symptoms.
Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in Quality of Life Scale
Time Frame: week 0, 2, 4, 6, 9, 12
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Assessment of life quality.
Minimum value: 0, maximum value:126, the higher scores mean a better outcome.
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week 0, 2, 4, 6, 9, 12
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Change from baseline in Cognitive function
Time Frame: Week 0, 12
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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:
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Week 0, 12
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH110-REC3-114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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