Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
sarcosine
sarcosine+ BE
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, cognitive function, N-methyl-D-aspartate receptor
Eligibility Criteria
Inclusion Criteria:
- The participants fulfill the criteria of schizophrenia according to the
- Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- The participants remain stable schizophrenic symptoms and receive stable antipsychotic regimens at last 8 weeks before enrollment.
- The participants agree to participate in the study and provide informed consent.
Exclusion Criteria:
- History of alcohol or substance dependence, history of epilepsy, head trauma or CNS diseases, history of major, untreated medical diseases, mental retardation, pregnancy or lactation
Sites / Locations
- Changhua Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
sarcosine
sarcosine+ BE
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Positive, negative, cognitive symptoms of schizophrenia, laboratory tests.
Secondary Outcome Measures
The subscales of PANSS,MATRICS, and serum DAAO levels.
Full Information
NCT ID
NCT01047592
First Posted
January 12, 2010
Last Updated
July 6, 2014
Sponsor
Chang-Hua Hospital
Collaborators
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01047592
Brief Title
Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
Official Title
N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang-Hua Hospital
Collaborators
China Medical University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. This project aims to compare the efficacy and safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2 g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were determined at the beginning and the end of the study. The efficacies of three groups are compared, and the characteristics of better responders are analyzed.
Detailed Description
We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on cognitive functions.The side effect assessments are also performed every 3 weeks. Side effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects, Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale. Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry , urine analysis, and EKG, will be checked at baseline and the end of week 12.
To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be checked at baseline and the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, cognitive function, N-methyl-D-aspartate receptor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sarcosine
Arm Type
Active Comparator
Arm Title
sarcosine+ BE
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
sarcosine
Intervention Description
sarcosine, 2 g/d , oral, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
sarcosine+ BE
Intervention Description
sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo,oral, for 12 weeks
Primary Outcome Measure Information:
Title
Positive, negative, cognitive symptoms of schizophrenia, laboratory tests.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The subscales of PANSS,MATRICS, and serum DAAO levels.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participants fulfill the criteria of schizophrenia according to the
Diagnostic and Statistic Manual, fourth edition (DSM-IV).
The participants remain stable schizophrenic symptoms and receive stable antipsychotic regimens at last 8 weeks before enrollment.
The participants agree to participate in the study and provide informed consent.
Exclusion Criteria:
History of alcohol or substance dependence, history of epilepsy, head trauma or CNS diseases, history of major, untreated medical diseases, mental retardation, pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-yuan Lin, MD
Organizational Affiliation
Changhua Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hsien-yuan Lane, MD,PHD
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Hospital
City
Changhua
ZIP/Postal Code
513
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
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