Study Stopped
The study was withdrawn by the sponsor.
NRX-1074 in Early Course Schizophrenia
A Placebo-controlled Two-dose Trial of NRX-1074 Early in the Course of Schizophrenia
1 other identifier
interventional
N/A
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedFebruary 5, 2016
February 1, 2016
November 9, 2015
February 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Psychiatric Rating Scale (BPRS) total score
Day 8
Secondary Outcomes (7)
Change in total score of Brief Psychiatric Rating Scale (BPRS) from baseline to Day 28
Baseline to Day 28
Change in total score of Clinical Assessment Interview for Negative Symptoms (CAINS) from baseline to day 28
Baseline to Day 28
Total score of MATRICS Consensus Cognitive Battery
Day 8
Total score of MATRICS Consensus Cognitive Battery
Day 28
Logical Memory Test of the Wechsler Memory Scale III
At Screening
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORGroup of enrolled subjects receiving two infusions of intravenous placebo (5% glucose solution)
NRX-1074 Dose Group
EXPERIMENTALGroup of enrolled subjects receiving two infusions of intravenous NRX-1074 (10 mg)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Naurex, Inc, an affiliate of Allergan plccollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
New York University Langone Medical Center/ Bellevue Hospital
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald C Goff, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 11, 2015
Primary Completion
August 1, 2020
Last Updated
February 5, 2016
Record last verified: 2016-02