Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00491569
Status:
COMPLETED
Last Update Posted:
2007-06-26
First Post:
2007-06-24
Brief Title:
Sarcosine or D-Serine Add-on Treatment for Chronic Schizophrenia
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
NMDA Enhancers in the Treatment of Schizophrenia Sarcosine vs D-Serine
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 gmd sarcosine 2 gmd 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
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 gmd sarcosine 2 gmd 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None