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

Sponsor ID
18-AVP-786-207
Clinicaltrials.gov ID
NCT03896945
EudraCT ID
2021-001352-33
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Terminated/Withdrawn
Sponsor ID
18-AVP-786-207
Trial Details
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Age
18 - 60 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Feb 2019 - May 2023
    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

    Study Summary

    This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

    Additional Study Details

    Phase
    Phase 2/Phase 3
    Study Drug
    Drug: Placebo
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    136
    Additional Study Details

    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.

    Exclusion Criteria

    • * Participants with current major depressive disorder (MDD)
    • * Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
    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

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    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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