Sarcosine or D-Serine Add-on Treatment for Chronic Schizophrenia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00491569
Study type	Interventional
Source	China Medical University Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	January 2005
Completion date	December 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05321602` - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder	Phase 1
Terminated	`NCT03230097` - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year	Phase 2
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Active, not recruiting	`NCT05726617` - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders	N/A
Not yet recruiting	`NCT03807388` - ReMindCare App for Patients From First Episode of Psychosis Unit.	N/A
Recruiting	`NCT02874573` - Tocilizumab in Schizophrenia	Phase 1
Terminated	`NCT02584114` - Brain Effects of Memory Training in Early Psychosis	N/A
Completed	`NCT02906553` - The Role of Nitric Oxide in Cognition in Schizophrenia	N/A
Terminated	`NCT02841956` - Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement	N/A
Completed	`NCT01981356` - Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis	Phase 0
Withdrawn	`NCT02213887` - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications	Phase 4
Recruiting	`NCT02009969` - Serial Comparisons of Abdominal and Neurological MRI Scans	N/A
Recruiting	`NCT02848469` - Irish Omega-3 Study	Phase 2
Completed	`NCT02648321` - Motivational Intervention for Physical Activity in Psychosis	N/A
Enrolling by invitation	`NCT00762866` - Psychiatric Genotype/Phenotype Project Repository
Completed	`NCT00484302` - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis	N/A
Completed	`NCT00130923` - Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder	Phase 4
Completed	`NCT00844922` - Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)	Phase 2
Completed	`NCT00455234` - Rapid Tranquillization Trial: TREC-India II	Phase 3
Completed	`NCT00253240` - Diabetes Screening, Risk Management and Disease Management in a High-Risk Mental Health Population

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.