D-Serine Treatment For Tardive Dyskinesia
This trial is active, not recruiting.
|Conditions||schizophrenia and schizoaffective disorder, tardive dyskinesia|
|Phase||phase 2/phase 3|
|Start date||January 2013|
|End date||January 2018|
|Trial size||16 participants|
|Trial identifier||NCT01804920, 1600|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Change in AIMS total score
time frame: biweekly during a period of 8 weeks
Male or female participants from 18 years up to 70 years old.
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.
|Official title||D-SERINE TREATMENT FOR TARDIVE DYSKINESIA|
|Principal investigator||Uriel Heresco-Levy, MD|
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