Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328276
Status:
COMPLETED
Last Update Posted:
2006-05-19
First Post:
2006-05-18
Brief Title:
Sarcosine N-Methylglycine Monotherapy for Schizophrenia
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
NMDA Enhancers in the Treatment of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2006-05
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:
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 gramsday effective dose with 1 gramday ineffective lower dose
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 gramsday effective dose with 1 gramday ineffective lower dose
Detailed Description:
In the study 20 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the two groups 1 gd and 2 gd with a double-blind manner Clinical manifestation Positive and Negative Syndrome Scale Scale for the Assessment of Negative Symptoms side effects and quality of life are evaluated every two weeks during the trial The efficacies of two groups are compared and the characteristics of better responders are analyzed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHRI-EX-94-9405PI | None | None | None |