D-Serine Treatment For Tardive Dyskinesia

Tardive Dyskinesia Clinical Trial

Official title:

D-SERINE TREATMENT FOR TARDIVE DYSKINESIA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01804920
• Other study ID #: 1600
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2019

Study information

• Verified date: October 2018
• Source: Herzog Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Schizoaffective Disorder
• Tardive Dyskinesia

Intervention

Dietary Supplement:
• D-serine

• Placebo

Locations

Country	Name	City	State
Israel	Herzog Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AIMS total score		biweekly during a period of 8 weeks