D-Serine Treatment For Tardive Dyskinesia

NCT ID: NCT01804920

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Schizophrenia and Schizoaffective Disorder; Tardive Dyskinesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: EXPERIMENTAL

D-serine

Intervention Type: DIETARY_SUPPLEMENT

Interventions

D-serine

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herzog Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heresco-Levi Uriel

Director - Psychiatry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uriel Heresco-Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Herzog Hospital

Locations

Herzog Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

1600

Identifier Type: -

Identifier Source: org_study_id