Psychotic Disorders Clinical Trial
Official title:
NMDA Enhancers in the Treatment of Schizophrenia
The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive
symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system
hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the
pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission
has been considered as a novel treatment approach. To date, there have been several trials
on NMDA enhancers reported. For example, sarcosine (N-methylglycine, a glycine transporter I
inhibitor) showed therapeutic effects not only in chronically stable patients but also in
acutely exacerbated ones when added-on to antipsychotics. In addition, sarcosine yields
excellent safety profiles, in comparison to current antipsychotics.
It remains unclear whether NMDA enhancers, such as sarcosine, can serve as monotherapy for
schizophrenia. The aims of this project are to examine the efficacy and safety of sarcosine
monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2
grams/day, effective dose, with 1 gram/day, ineffective lower dose.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV). - Free from antipsychotics for at least 7 days before enrollment. - Agree to participate in the study and provide informed consent Exclusion Criteria: - Meet DSM-IV criteria of major mood disorder, current substance dependence or mental retardation - History of epilepsy, head trauma or CNS diseases - Major, untreated medical diseases - Pregnancy or lactation - Receiving psychotropic agents or depot within three months prior to study entry |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Psychiatry, China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital | National Health Research Institutes, Taiwan, National Science Council, Taiwan |
Taiwan,
Lane HY, Chang YC, Liu YC, Chiu CC, Tsai GE. Sarcosine or D-serine add-on treatment for acute exacerbation of schizophrenia: a randomized, double-blind, placebo-controlled study. Arch Gen Psychiatry. 2005 Nov;62(11):1196-204. — View Citation
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