Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
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Purpose
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=20), sarcosine(2 g/d) + BE(1 g/d ) (N=20), and placebo(N=20). 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: sarcosine Drug: sarcosine+ BE Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment |
- Positive, negative, cognitive symptoms of schizophrenia, laboratory tests. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- The subscales of PANSS,MATRICAS, and serum levels of excitatory amino acid. levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: sarcosine |
Drug: sarcosine
sarcosine, 2 g/d , oral, for 12 weeks
|
| Active Comparator: sarcosine+ BE |
Drug: sarcosine+ BE
sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks
|
| Placebo Comparator: Placebo |
Drug: placebo
placebo,oral, for 12 weeks
|
Detailed Description:
We will measure clinical efficacy every 3 weeks during the treatment. Clinical efficacy will be assessed with Positive and Negative Syndrome Scale (PANSS), Scale for the Assessment of Negative Symptoms (SANS), and Clinical Global Impression Scale.
At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on neurocognitive 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. 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Chun-yuan Lin, MD | 886-4-8298686 ext 1308 | linjyuan@gmail.com |
| Contact: Hsien-yuan Lane, MD,PHD | 886-4-22052121 | hylane@mail.cmuh.org.tw |
| Taiwan | |
| Changhua Hospital | Recruiting |
| Changhua, Taiwan, 513 | |
| Contact: Chun-yuan Lin, MD 886-4-8298686 ext 1308 linjyuan@gmail.com | |
| Principal Investigator: Chun-yuan Lin, MD | |
| Principal Investigator: | Chun-yuan Lin, MD | Changhua Hospital |
| Study Director: | Hsien-yuan Lane, MD,PHD | China Medical University Hospital |
| Study Director: | Guochuan E Tsai, MD, PhD | Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, California |
More Information
No publications provided
| Responsible Party: | Chun Yuan Lin , MD, Attending, Chang-Hua Hospital |
| ClinicalTrials.gov Identifier: | NCT01047592 History of Changes |
| Other Study ID Numbers: | DMR98-IR-014, HAC9814 |
| Study First Received: | January 12, 2010 |
| Last Updated: | November 23, 2012 |
| Health Authority: | Taiwan: Department of Health United States: Food and Drug Administration |
Keywords provided by Chang-Hua Hospital:
|
Schizophrenia cognitive function N-methyl-D-aspartate receptor |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders N-Methylaspartate Excitatory Amino Acid Agonists |
Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013