Overview

This trial is active, not recruiting.

Conditions schizophrenia and schizoaffective disorder, tardive dyskinesia
Treatments d-serine, placebo
Phase phase 2/phase 3
Sponsor Herzog Hospital
Start date January 2013
End date January 2018
Trial size 16 participants
Trial identifier NCT01804920, 1600

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Random assignment, parallel group, double blind, placebo controlled 8 weeks trial. First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment
d-serine
(Placebo Comparator)
Random assignment, parallel group, double blind, placebo controlled 8 weeks trial. First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment
placebo

Primary Outcomes

Measure
Change in AIMS total score
time frame: biweekly during a period of 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. age 18-70; 2. 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; 3. history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks; 4. 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: 1. meeting criteria for other DSM-IV Axis I diagnoses; 2. presence of a neurological disorder or history of significant head injury; 3. substance abuse or alcoholism during entire lifetime; 4. are judged clinically to be at suicidal or homicidal risk; 5. 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.

Additional Information

Official title D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
Principal investigator Uriel Heresco-Levy, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Herzog Hospital.