Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Comparison Design (SPCD) Study to Assess the Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) as an Adjunctive Treatment for Patients With Residual Schizophrenia
1 other identifier
interventional
145
1 country
17
Brief Summary
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started Sep 2015
17 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
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2017
CompletedResults Posted
Study results publicly available
September 16, 2020
CompletedSeptember 16, 2020
August 1, 2020
1.9 years
June 18, 2015
July 20, 2020
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12
The NSA-16 is a measure of the presence, severity, and range of negative symptoms associated with schizophrenia. It has a high interrater and test-retest reliability across languages and cultures. The NSA-16 uses a 5-factor model to describe negative symptoms: (1) communication, (2) emotion/affect, (3) social involvement, (4) motivation, and (5) retardation. The possible NSA-16 total score ranges from 16 to 96, with a higher score indicating a worse condition. Change was Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Secondary Outcomes (29)
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 and Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Change From Baseline in the PANSS Negative Subscale Score at Week 6 and Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Change From Baseline in the PANSS Marder Negative Factor Score at Week 6 and Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Change From Baseline in the PANSS Prosocial Factor Subscale Score at Week 6 at Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Change From Baseline in the PANSS Positive Subscale Score at Week 6 and Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
- +24 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo capsules administered twice a day over a 12-week period
AVP-786
EXPERIMENTALAVP-786 dose 2 capsules administered twice a day over a 12-week period
Interventions
Eligibility Criteria
You may qualify if:
- Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
- Patients must meet PANSS criteria
- Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose
You may not qualify if:
- Patients with current major depressive disorder (MDD)
- Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
- Patients currently using anticholinergic medications
- Recent in-patient hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Cerritos, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
National City, California, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
Marlton, New Jersey, United States
Unknown Facility
Jamaica, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sanjay Dubé, M.D.
- Organization
- Avanir Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
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
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 23, 2015
Study Start
September 1, 2015
Primary Completion
July 21, 2017
Study Completion
July 21, 2017
Last Updated
September 16, 2020
Results First Posted
September 16, 2020
Record last verified: 2020-08