Back to resultsEarly Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
Primary Purpose
Prodromal Schizophrenia
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
NMDAE
Placebo Cap
Sponsored by
About this trial
This is an interventional treatment trial for Prodromal Schizophrenia focused on measuring Schizophrenia, Prodrome, NMDA
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry, China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NMDAE
Placebo
Arm Description
An NMDA enhancer
Placebo
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
Change from baseline in Clinical Global Impression
Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.
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.
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.
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.
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)
Full Information
NCT ID
NCT05052853
First Posted
September 8, 2021
Last Updated
February 7, 2023
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05052853
Brief Title
Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
Official Title
Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prodromal Schizophrenia
Keywords
Schizophrenia, Prodrome, NMDA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMDAE
Arm Type
Experimental
Arm Description
An NMDA enhancer
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
NMDAE
Intervention Description
Use of an NMDA enhancer for the treatment of prodromal schizophrenia .
Intervention Type
Drug
Intervention Name(s)
Placebo Cap
Intervention Description
Use of placebo as a comparator
Primary Outcome Measure Information:
Title
Change from baseline in Scale of Prodromal Symptoms [SOPS] total score
Description
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).
Time Frame
week 0, 2, 4, 6, 9, 12
Secondary Outcome Measure Information:
Title
Change from baseline in SOPS Positive Symptom Scale score
Description
Assessment of positive prodromal symptoms. Minimum value: 0, maximum value: 30, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in SOPS Negative Symptom Scale score
Description
Assessment of negative prodromal symptoms. Minimum value: 0, maximum value: 36, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in SOPS Disorganization Symptom Scale score
Description
Assessment of disorganization prodromal symptoms. Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in SOPS General Symptom Scale score
Description
Assessment of general prodromal symptoms. Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in Scales for the Assessment of Negative Symptoms (SANS) total score
Description
Assessment of schizophrenia negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in Clinical Global Impression
Description
Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in Global Assessment of Functioning
Description
Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in Hamilton Rating Scale for Depression
Description
Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in Quality of Life Scale
Description
Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome.
Time Frame
week 0, 2, 4, 6, 9, 12
Title
Change from baseline in Cognitive function
Description
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)
Time Frame
Week 0, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Yuan Lane, M.D., Ph.D
Phone
886 4 22052121
Ext
1855
Email
hylane@gmail.com
Facility Information:
Facility Name
Department of Psychiatry, China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Yuan Lane, M.D., Ph.D
Phone
886 4 22052121
Ext
1855
Email
hylane@gmail.com
12. IPD Sharing Statement
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Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
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