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

Otsuka

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: AVP-786; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03896945

18-AVP-786-207

2021-001352-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsules will be administered orally twice a day over a 15-week period.

Treatment:

Drug: Placebo

AVP-786

Experimental group

Description:

AVP-786 capsules will be administered orally twice a day over a 15-week period.

Treatment:

Drug: AVP-786