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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    370
  • sponsor
    Avanir Pharmaceuticals
Updated on 2 June 2021
Investigator
Jurandir Araujo
Primary Contact
Clinical Research Site (7.0 mi away) Contact
+53 other location
psychiatric disorder
antipsychotics
typical antipsychotic

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.

Details
Condition Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), schizophrenia disorders
Treatment Placebo, AVP-786
Clinical Study IdentifierNCT03896945
SponsorAvanir Pharmaceuticals
Last Modified on2 June 2021

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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