D-Serine Treatment For Tardive Dyskinesia

D-SERINE TREATMENT FOR TARDIVE DYSKINESIA

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01804920

Enrollment

Registered

2013-03-05

Start date

2013-01-31

Completion date

2019-01-31

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia and Schizoaffective Disorder, Tardive Dyskinesia

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.

Interventions

DIETARY_SUPPLEMENTD-serine

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in AIMS total score	biweekly during a period of 8 weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026