A clinical trial to assess the efficacy, safety, and tolerability of AVP-786 versus placebo for the treatment of negative symptoms of schizophrenia

Phase 1

• Conditions: egative symptoms of schizophrenia; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-001352-33-BG
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-26
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. Patients 18 to 60 years of age, inclusive, at time of informed consent.
2. 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
3. Participants must have well-controlled positive symptoms and
prominent negative symptoms as defined by Positive and Negative
Syndrome Scale (PANSS) criteria.
4. Participants should be treated with second-generation atypical
antipsychotic drug (SGA) including long-acting injectable (LAI)
treatments, are eligible if they are stable and adherent to their dosing
schedule.
5. 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.
Please refer to the protocol for complete list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 370
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participants with current major depressive disorder (MDD)
2. Patients with a diagnosis of schizoaffective disorder or bipolar
disorder.
3. Participants currently using anticholinergic medications
4. Participants recently hospitalized as in-patients
Please refer to protocol for complete list of exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified