Clincosm LogoSign in Get a demo

D-Serine Treatment For Tardive Dyskinesia

Sponsor
Herzog Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01804920
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
72
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: D-serine
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2013
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in AIMS total score [biweekly during a period of 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herzog Hospital Jerusalem Israel

Sponsors and Collaborators

  • Herzog Hospital

Investigators

  • Principal Investigator: Uriel Heresco-Levy, MD, Herzog Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heresco-Levi Uriel, Director - Psychiatry Department, Herzog Hospital
ClinicalTrials.gov Identifier:
NCT01804920
Other Study ID Numbers:
  • 1600
First Posted:
Mar 5, 2013
Last Update Posted:
Oct 11, 2018
Last Verified:
Oct 1, 2018
Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Schizophrenia
Psychotic Disorders

Study Results

No Results Posted as of Oct 11, 2018