Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
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|ClinicalTrials.gov Identifier: NCT03896945|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : March 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Placebo Drug: AVP-786||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||February 15, 2019|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||November 2024|
Placebo Comparator: Placebo
Placebo capsules will be administered orally twice a day over a 15-week period.
AVP-786 capsules will be administered orally twice a day over a 15-week period.
- Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score [ Time Frame: Baseline; Week 15 ]
- Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score [ Time Frame: Baseline; Week 15 ]
- Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline; Week 15 ]
- Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score [ Time Frame: Baseline; Week 15 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896945
|Contact: Clinical Transparencyfirstname.lastname@example.org|
|Responsible Party:||Otsuka Pharmaceutical Development & Commercialization, Inc.|
|Other Study ID Numbers:||
2021-001352-33 ( EudraCT Number )
|First Posted:||April 1, 2019 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.|
|Access Criteria:||Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Schizophrenia Spectrum and Other Psychotic Disorders