Adjunctive Treatment for Decreasing Symptoms of Schizophrenia

University of Maryland Baltimore (UMB)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Drug: glycine

Drug: d-cycloserine

Drug: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00222235

R01MH059807 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.

Full description

A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.

Multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.

Sex

All

Ages

18 to 54 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diagnosis of schizophrenia or schizoaffective disorder
stable, enduring negative symptoms above a certain level (SANS >19)
clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
extrapyramidal symptoms measured on SAS below 9
on stable antipsychotic regimen (not including clozapine)

Exclusion criteria

alcohol or substance dependence within last six months
alcohol or substance abuse within last month
organic brain disorder
medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
Female participants could not be pregnant and were required to be using a documented method of contraception.