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D-Serine Treatment For Tardive Dyskinesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Herzog Hospital
Sponsor:
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital
ClinicalTrials.gov Identifier:
NCT01804920
First received: March 3, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-SERINE TREATMENT FOR TARDIVE DYSKINESIA

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: January 2017 (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


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804920

Contacts
Contact: Uriel Heresco-Levy, MD +972-2-5316906 urielh@ekmd.huji.ac.il

Locations
Israel
Herzog Hospital Recruiting
Jerusalem, Israel
Contact: Adi Sasson, MD    +972-2-5316917    adys@herzoghospital.org   
Herzog Hospital Recruiting
Jerusalem, Israel
Contact: Adi Sasson, MD    +972-2-5316817    adys@herzoghospital.org   
Sponsors and Collaborators
Herzog Hospital
Investigators
Principal Investigator: Uriel Heresco-Levy, MD Herzog Hospital
  More Information

No publications provided

Responsible Party: Heresco-Levi Uriel, Director - Psychiatry Department, Herzog Hospital
ClinicalTrials.gov Identifier: NCT01804920     History of Changes
Other Study ID Numbers: 1600
Study First Received: March 3, 2013
Last Updated: August 19, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Psychotic Disorders
Schizophrenia
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014