D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia

Yale University

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Behavioral: Cognitive retraining

Drug: D-serine

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00237848

RPA/020/03

103T-363

1R01DA022495 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.

Full description

This study is based on the hypothesis that by increasing NMDA receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of schizophrenia or schizoaffective disorder
Clinically stable
Treated with antipsychotic medications for at least 6 months in the past, and on a stable dose of the same antipsychotic medication over the past month
Not pregnant or lactating

Exclusion criteria

Other current or past DSM-IV Axis I diagnosis
Calgary Depression scale score >10 or Simpson-Angus Rating Scale score > 20
Currently treated with clozapine, lamotrigine or carbamazepine, or defined as treatment refractory
Substance abuse or dependence within the past 3 months, except for nicotine
Wechsler Adult Intelligence Scale-Revised score < 70
Significant recent (within past 3 months) risk of committing suicide
Abnormal thyroid function tests within the last 6 months
Previous treatment with D-serine
History of evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the trial
Clinically significant abnormal laboratory test results at screening
ECT treatment within the past two months