Back to resultsD-Serine Treatment For Tardive Dyskinesia
Primary Purpose
Schizophrenia and Schizoaffective Disorder, Tardive Dyskinesia
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
D-serine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia and Schizoaffective Disorder
Eligibility Criteria
Inclusion Criteria:
- age 18-70;
- 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;
- history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
- 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:
- meeting criteria for other DSM-IV Axis I diagnoses;
- presence of a neurological disorder or history of significant head injury;
- substance abuse or alcoholism during entire lifetime;
- are judged clinically to be at suicidal or homicidal risk;
- 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.
Sites / Locations
- Herzog Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
D-serine adjuvant treatment
Placebo adjuvant treatment
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in AIMS total score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804920
Brief Title
D-Serine Treatment For Tardive Dyskinesia
Official Title
D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herzog Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Schizoaffective Disorder, Tardive Dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-serine adjuvant treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo adjuvant treatment
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
D-serine
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in AIMS total score
Time Frame
biweekly during a period of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-70;
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;
history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
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:
meeting criteria for other DSM-IV Axis I diagnoses;
presence of a neurological disorder or history of significant head injury;
substance abuse or alcoholism during entire lifetime;
are judged clinically to be at suicidal or homicidal risk;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uriel Heresco-Levy, MD
Organizational Affiliation
Herzog Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzog Hospital
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
D-Serine Treatment For Tardive Dyskinesia
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