~19 spots leftby Apr 2026

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 profile image

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah profile image

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