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

Yale University logo

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)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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