Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

Key facts

Study ID

NCT03896945

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

136

Starts

2019-02-15

Expected to finish

2023-05-23

Last updated by the study team

2024-05-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.

You may not qualify if…

• Participants with current major depressive disorder (MDD)
• Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
• Participants currently using anticholinergic medications
• Participants recently hospitalized as in-patients

Where it is running

• Clinical Research Site #840-041 — Anaheim, California, United States
• Clinical Research Site #840-013 — Bellflower, California, United States
• Clinical Research Site #840-079 — Costa Mesa, California, United States
• Clinical Research Site #840-027 — Culver City, California, United States
• Clinical Research Site #840-006 — Garden Grove, California, United States
• Clinical Research Site #840-026 — Glendale, California, United States
• Clinical Research Site# 840-067 — La Habra, California, United States
• Clinical Research Site# 840-083 — Lafayette, California, United States
• Clinical Research Site 840-002 — Lemon Grove, California, United States
• Clinical Research Site — Oakland, California, United States
• Clinical Research Site #840-035 — Oceanside, California, United States
• Clinical Research Site# 840-010 — Panorama City, California, United States
• Clinical Research Site #840-012 — Riverside, California, United States
• Clinical Research Site# 840-081 — San Bernardino, California, United States
• Clinical Research Site #840-005 — San Diego, California, United States
• Clinical Research Site #840-096 — Santee, California, United States
• Clinical Research Site #840-015 — Torrance, California, United States
• Clinical Research Site# 840-094 — Doral, Florida, United States
• Clinical Research Site #840-046 — Hollywood, Florida, United States
• Clinical Research Site Site #840-093 — Homestead, Florida, United States
• Clinical Research Site #840-062 — Lakeland, Florida, United States
• Clinical Research Site #840-024 — Largo, Florida, United States
• Clinical Research Site #840-032 — Miami, Florida, United States
• Clinical Research Site #840-080 — Miami, Florida, United States
• Clinical Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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