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D-Serine Treatment For Tardive Dyskinesia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital Identifier:
First received: March 3, 2013
Last updated: August 23, 2016
Last verified: August 2016

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.

Condition Intervention Phase
Schizophrenia and Schizoaffective Disorder
Tardive Dyskinesia
Dietary Supplement: D-serine
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • Change in AIMS total score [ Time Frame: biweekly during a period of 8 weeks ]

Enrollment: 16
Study Start Date: January 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-serine adjuvant treatment

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

Dietary Supplement: D-serine
Placebo Comparator: Placebo adjuvant treatment

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

Dietary Supplement: Placebo


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01804920

Herzog Hospital
Jerusalem, Israel
Sponsors and Collaborators
Herzog Hospital
Principal Investigator: Uriel Heresco-Levy, MD Herzog Hospital
  More Information

Responsible Party: Heresco-Levi Uriel, Director - Psychiatry Department, Herzog Hospital Identifier: NCT01804920     History of Changes
Other Study ID Numbers: 1600
Study First Received: March 3, 2013
Last Updated: August 23, 2016

Additional relevant MeSH terms:
Psychotic Disorders
Movement Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 24, 2017