Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
Recruiting in Palo Alto (17 mi)
+119 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Avanir Pharmaceuticals
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new medication called AVP-786 to see if it can help people with schizophrenia who have negative symptoms like lack of motivation and social withdrawal. The study will compare AVP-786 to another group to check its benefits.
Research Team
Eligibility Criteria
Inclusion Criteria
Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
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Exclusion Criteria
Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
Participants currently using anticholinergic medications
Participants recently hospitalized as in-patients
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Treatment Details
Interventions
- AVP-786 (Other)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AVP-786Experimental Treatment1 Intervention
AVP-786 capsules will be administered orally twice a day over a 15-week period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules will be administered orally twice a day over a 15-week period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avanir Pharmaceuticals
Lead Sponsor
Trials
32
Recruited
12,100+
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
Trials
271
Recruited
170,000+
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University