NRX-1074 in Early Course Schizophrenia

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to examine the effectiveness of NRX-1074 in the treatment of negative symptoms and cognition in schizophrenia compared to other agents at the glycine site which have demonstrated inconsistent results for negative symptoms. In addition to testing efficacy, we will examine the time course of response of symptoms as well as any effects on memory consolidation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Naurex, Inc; Naurex, Inc, an affiliate of Allergan plc

Criteria

Inclusion Criteria:

• Age 18-50

• Diagnosis of Schizophrenia, Schizophreniform, or schizoaffective disorder as per DSM-V criteria

• Within five years of onset of illness

• Treated with any antipsychotic agent except clozapine at an adequate, stable dose for at least 8 weeks.

• A score of at least 4 (moderate) on at least one BPRS negative symptom item.

Exclusion Criteria:

• Serious or unstable medical illness

• Pregnant or nursing

• Abuse of substances except nicotine in the previous 6 weeks (excluding cannabis use)

• Positive urine toxicology at screening

• Experiencing serious suicidal or homicidal ideation within six months

• Treatment with clozapine