D-Serine Treatment For Tardive Dyskinesia

Herzog Hospital

Status: Unknown

Conditions: Tardive Dyskinesia; Schizophrenia and Schizoaffective Disorder

Treatments: Dietary Supplement: Placebo; Dietary Supplement: D-serine

Study type: Interventional

Funder types: Other

Identifiers

NCT01804920

1600

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

D-serine adjuvant treatment

Experimental group

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

Treatment:

Dietary Supplement: D-serine

Placebo adjuvant treatment

Placebo Comparator group

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

Treatment:

Dietary Supplement: Placebo