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D-Serine Treatment For Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT01804920
Recruitment Status : Unknown
Verified August 2016 by Heresco-Levi Uriel, Herzog Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
Study Start Date : January 2013
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Serine

Arm Intervention/treatment
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



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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804920


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

Responsible Party: Heresco-Levi Uriel, Director - Psychiatry Department, Herzog Hospital
ClinicalTrials.gov Identifier: NCT01804920     History of Changes
Other Study ID Numbers: 1600
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Dyskinesia, Drug-Induced
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms