Overview

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

Status:
Recruiting

Trial end date:
2022-08-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Avanir Pharmaceuticals

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.

- 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.

Exclusion Criteria:

- 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