D-SERINE TREATMENT FOR TARDIVE DYSKINESIA

Herzog Hospital1 site in 1 country16 target enrollmentJanuary 2013

ConditionsSchizophrenia and Schizoaffective Disorder Tardive Dyskinesia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia and Schizoaffective Disorder
Sponsor: Herzog Hospital
Enrollment: 16
Locations: 1
Primary Endpoint: Change in AIMS total score
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.

The hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

January 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Herzog Hospital

Responsible Party

Principal Investigator

Heresco-Levi Uriel

Director - Psychiatry Department

Herzog Hospital

Eligibility Criteria

Inclusion Criteria

•diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;
•history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
•fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.

Exclusion Criteria

•meeting criteria for other DSM-IV Axis I diagnoses;
•presence of a neurological disorder or history of significant head injury;
•substance abuse or alcoholism during entire lifetime;
•are judged clinically to be at suicidal or homicidal risk;
•female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.