NRX-1074 in Early Course Schizophrenia
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NRX-1074
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Naurex, Intravenous Treatment, NRX-1074
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
- New York University Langone Medical Center/ Bellevue Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
NRX-1074 Dose Group
Arm Description
Group of enrolled subjects receiving two infusions of intravenous placebo (5% glucose solution)
Group of enrolled subjects receiving two infusions of intravenous NRX-1074 (10 mg)
Outcomes
Primary Outcome Measures
Brief Psychiatric Rating Scale (BPRS) total score
Secondary Outcome Measures
Change in total score of Brief Psychiatric Rating Scale (BPRS) from baseline to Day 28
At each time point (Day 1, Day 7, Day 8, Day 14, Day 21), contrasts between GLYX-13 and placebo will be obtained. The overall contrasts for combined GLYX-13 dose group against placebo were also estimated and tested at each time point.
Change in total score of Clinical Assessment Interview for Negative Symptoms (CAINS) from baseline to day 28
At each time point (Day 8, Day 14), contrasts between GLYX-13 and placebo will be obtained. The overall contrasts for combined GLYX-13 dose group against placebo were also estimated and tested at each time point.
Total score of MATRICS Consensus Cognitive Battery
Total score of MATRICS Consensus Cognitive Battery
Logical Memory Test of the Wechsler Memory Scale III
Logical Memory Test of the Wechsler Memory Scale III
Logical Memory Test of the Wechsler Memory Scale III
Full Information
NCT ID
NCT02603458
First Posted
November 9, 2015
Last Updated
February 4, 2016
Sponsor
NYU Langone Health
Collaborators
Naurex, Inc, an affiliate of Allergan plc
1. Study Identification
Unique Protocol Identification Number
NCT02603458
Brief Title
NRX-1074 in Early Course Schizophrenia
Official Title
A Placebo-controlled Two-dose Trial of NRX-1074 Early in the Course of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdrawn by the sponsor.
Study Start Date
undefined (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Naurex, Inc, an affiliate of Allergan plc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Investigators propose to conduct a 4-week, randomized, double-blind, placebo-controlled trial in which NRX-1074 will be intravenously administered twice. Subjects will be 62 stable patients ages 18-50 within five years of onset of schizophrenia, treated with any antipsychotic except clozapine at an adequate, stable dose for at least 8 weeks. This study will be conducted by the Schizophrenia Program of the NYU Langone Medical Center and at the Psychiatry Outpatient Clinic of Bellevue Hospital located in New York, NY.
Upon signing consent, patients will undergo screening procedures to assess eligibility. A diagnosis of schizophrenia or schizophreniform disorder will be determined by the Structured Clinical Interview for DSM IV (SCID) completed by a research clinician using all available clinical data and will be confirmed by consensus diagnosis. A comprehensive medical review and physical exam, including routine laboratory tests, will be completed to identify unstable medical illness. A urine toxicology screen and, in females, a pregnancy test will also be performed. A research assistant will complete the Logical Memory Test portion of the Weschler Memory Scale-III (WMS-III).
Subjects who meet study eligibility criteria will complete the baseline visit which will include a one minute infusion of NRX-1074 and the following clinical assessments: Brief Psychiatric Rating Scale (BPRS), Clinical Assessment Interview for Negative Symptoms (CAINS), Calgary Depression Scale for Schizophrenia (CDSS), InterSePT Scale for Suicidal Thinking (ISST), Clinical Global Impression (CGI), and Systematic Assessment for Treatment Emergent Events (SAFTEE). The BPRS, SAFTEE, and ISST will be conducted twice, both before and after the infusion. The remaining assessments will be conducted before the infusion. A cognitive assessment, the Logical Memory Test of the WMS-III, will also be conducted after the infusion.
Patients will return for a visit one day after their baseline infusion, where the BPRS, ISST, CGI, and Logical Memory Test will be conducted. Their next visit will be one week later, where they receive their second NRX-1074 infusion, and will be similar in format to the first baseline infusion with the exception of CAINS and CDSS. One day after the second infusion, patients will be administered the BPRS, CAINS, CDSS, ISST, CGI, and MATRICS Consensus Cognitive Battery (MCCB). Patients will then return weekly for three weeks until Day 28.
The BPRS and ISST will be conducted during the Baseline, Day 1, Day 7, Day 8, Day 14, Day 21, and Day 28 visits. The CGI will be administered during Baseline, Day 1, Day 7, Day 8, Day 14, and Day 28. The CAINS and CDSS will be administered at Baseline, Day 8, Day 14, and Day 28. The SAFTEE will be conducted on Baseline, Day 7, Day 14, Day 21, and Day 28. The Logical Memory Test will be administered during Screening Visit 1, Screening Visit 2, Baseline, and Day 1. The MATRICS will be conducted on Day 8 and Day 28.
The primary outcome measure is the change in BPRS total score from Baseline to 24 hours post infusion on Day 8. Secondary outcome measures include the positive and negative symptom subscales on the BPRS, the CAINS total score, the composite score on the MATRICS 24 hours after the second infusion and the Logical Memory Test compared to placebo one hour after the first infusion (Baseline).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Naurex, Intravenous Treatment, NRX-1074
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group of enrolled subjects receiving two infusions of intravenous placebo (5% glucose solution)
Arm Title
NRX-1074 Dose Group
Arm Type
Experimental
Arm Description
Group of enrolled subjects receiving two infusions of intravenous NRX-1074 (10 mg)
Intervention Type
Drug
Intervention Name(s)
NRX-1074
Intervention Description
Participants will receive two IV NRX-1074 infusions 1 week apart, each lasting 1 minute.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar IV solution
Intervention Description
Patients will receive two IV placebo infusions 1 week apart, each lasting 1 minute.
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS) total score
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Change in total score of Brief Psychiatric Rating Scale (BPRS) from baseline to Day 28
Description
At each time point (Day 1, Day 7, Day 8, Day 14, Day 21), contrasts between GLYX-13 and placebo will be obtained. The overall contrasts for combined GLYX-13 dose group against placebo were also estimated and tested at each time point.
Time Frame
Baseline to Day 28
Title
Change in total score of Clinical Assessment Interview for Negative Symptoms (CAINS) from baseline to day 28
Description
At each time point (Day 8, Day 14), contrasts between GLYX-13 and placebo will be obtained. The overall contrasts for combined GLYX-13 dose group against placebo were also estimated and tested at each time point.
Time Frame
Baseline to Day 28
Title
Total score of MATRICS Consensus Cognitive Battery
Time Frame
Day 8
Title
Total score of MATRICS Consensus Cognitive Battery
Time Frame
Day 28
Title
Logical Memory Test of the Wechsler Memory Scale III
Time Frame
At Screening
Title
Logical Memory Test of the Wechsler Memory Scale III
Time Frame
Baseline
Title
Logical Memory Test of the Wechsler Memory Scale III
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald C Goff, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New York University Langone Medical Center/ Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study has been withdrawn by the sponsor, so the plan to share data has not been discussed and is undecided.
Learn more about this trial
NRX-1074 in Early Course Schizophrenia
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