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

Study Identifier:
18-AVP-786-207
ClinicalTrials.gov Identifier:
NCT03896945
EudraCT Identifier:
2021-001352-33
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Terminated/Withdrawn
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Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: Placebo
  • Drug: AVP-786
Date
Feb 2019 - May 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion 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

Protocol 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.

Study Locations

Location
Status
Location
Clinical Research Site
Little Rock, Arkansas, United States, 72209
Status
N/A
Location
Clinical Research Site #840-041
Anaheim, California, United States, 92805
Status
N/A
Location
Clinical Research Site #840-013
Bellflower, California, United States, 90706
Status
N/A
Location
Clinical Research Site #840-079
Costa Mesa, California, United States, 92626
Status
N/A
Location
Clinical Research Site #840-027
Culver City, California, United States, 90230
Status
N/A
Location
Clinical Research Site #840-006
Garden Grove, California, United States, 92845
Status
N/A
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July 2025 01US25EUC0279

Requirements information
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

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