A multicenter, randomized, double-blind, placebo-controlled, parallel-arm study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of negative symptoms of schizophrenia

Avanir Pharmaceuticals, Inc.0 个研究点目标入组 370 人开始时间: 2021年8月5日最近更新: 2022年3月2日

试验速览

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•- 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.
•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

•- 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

发起方