D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

Yale University

Status and phase: Completed; Phase 3

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Placebo; Behavioral: Cognitive Retraining (CRT); Behavioral: Cognitive Retraining Placebo; Drug: D-serine

Study type: Interventional

Funder types: Other

Identifiers

NCT00237809

23594

DF01-015

Details and patient eligibility

About

This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (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.

Full description

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: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

• Pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

104 participants in 4 patient groups

Drug and control CRT

Experimental group

Description:

D-serine/control

Treatment:

Behavioral: Cognitive Retraining Placebo

Drug: D-serine

Drug and CRT

Experimental group

Description:

D-serine/cog rehab

Treatment:

Behavioral: Cognitive Retraining (CRT)

Drug: D-serine

Placebo Drug and Placebo CRT

Experimental group

Description:

Placebo/control

Treatment:

Drug: Placebo

Behavioral: Cognitive Retraining Placebo

Placebo Drug and CRT

Experimental group

Description:

Placebo/cog rehab

Treatment:

Drug: Placebo

Behavioral: Cognitive Retraining (CRT)