D-Serine Treatment For Tardive Dyskinesia

NCT01804920 | Unknown DMC

• 1 other identifier: 1600
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in AIMS total score

  biweekly during a period of 8 weeks

Study Arms (2)

D-serine adjuvant treatment

EXPERIMENTAL

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 adjuvant treatment

PLACEBO COMPARATOR

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

Interventions

D-serine DIETARY_SUPPLEMENT

D-serine adjuvant treatment

Placebo DIETARY_SUPPLEMENT

Placebo adjuvant treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herzog Hospital: lead

Study Sites (1)

Herzog Hospital

Jerusalem, Israel

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Tardive Dyskinesia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uriel Heresco-Levy, MD

  Herzog Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Psychiatry Department

Study Record Dates

• First Submitted: March 3, 2013
• First Posted: March 5, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

IL (1)