Sarcosine or D-Serine Add-on Treatment for Chronic Schizophrenia
- Conditions
- SchizophreniasPsychosesPsychotic DisordersSchizophrenic Disorders
- Registration Number
- NCT00491569
- Lead Sponsor
- China Medical University Hospital
- Brief Summary
Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients.
The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine, a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.
- Detailed Description
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 regarded as a novel treatment approach. To date, there have been several reported trials on NMDA enhancers. Both sarcosine (N-methylglycine, a glycine transporter I inhibitor) and D-serine (a potent NMDA-glycine site agonist) showed therapeutic effects in chronically stable patients. Interestingly, sarcosine appeared more efficacious than D-serine in acutely exacerbated ones when added-on to antipsychotics. Both sarcosine and D-serine yielded excellent safety profiles.
It remains unclear whether sarcosine can be also more efficacious than D-serine in the treatment for chronically stable schizophrenia. The aim of this project is to examine the efficacy and safety of add-on treatment of sarcosine vs. D-serine in chronically stable schizophrenia patients who have been stabilized with antipsychotics.
In the study, 60-75 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the three groups (2 gm/d sarcosine, 2 gm/d D-serine, or placebo) with a double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale \[PANSS\], side effects and quality of life (QOL) are evaluated every two weeks during the trial.. The efficacies of three groups are compared.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- Agree to participate in the study and provide informed consent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total scores of Positive and Negative Syndrome Scale (PANSS) and Quality of Life (QOL) 6 weeks
- Secondary Outcome Measures
Name Time Method Subscales of PANSS 6 weeks
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung, Taiwan