Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
- Registration Number
- NCT03896945
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 136
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo capsules will be administered orally twice a day over a 15-week period. AVP-786 AVP-786 AVP-786 capsules will be administered orally twice a day over a 15-week period.
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score Baseline; Week 15
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score Baseline; Week 15 Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score Baseline; Week 15 Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score Baseline; Week 15
Trial Locations
- Locations (60)
Clinical Research Site# 840-083
🇺🇸Lafayette, California, United States
Clinical Research Site# 840-094
🇺🇸Doral, Florida, United States
Clinical Research Site #840-028
🇺🇸Berlin, New Jersey, United States
Clinical Research Site #840-032
🇺🇸Miami, Florida, United States
Clinical Research Site 840-002
🇺🇸Lemon Grove, California, United States
Clinical Research Site #840-046
🇺🇸Hollywood, Florida, United States
Clinical Research Site# 840-081
🇺🇸San Bernardino, California, United States
Clinical Research Site #840-096
🇺🇸Santee, California, United States
Clinical Research Site #840-080
🇺🇸Miami, Florida, United States
Clinical Research Site #840-088
🇺🇸Atlanta, Georgia, United States
Clinical Research Site #840-090
🇺🇸Springfield, Illinois, United States
Clinical Research Site #840-074
🇺🇸Charlotte, North Carolina, United States
Clinical Research Site #840-052
🇺🇸Middleburg Heights, Ohio, United States
Clinical Research Site #840-018
🇺🇸Richardson, Texas, United States
Clinical Research Site #840-069
🇺🇸Springville, Utah, United States
Clinical Research Site #100-007
🇧🇬Plovdiv, Bulgaria
Clinical Research Site #840-065
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Site #616-002
🇵🇱Bełchatów, Poland
Clinical Research Site #840-058
🇺🇸Fort Worth, Texas, United States
Clinical Research Site #840-041
🇺🇸Anaheim, California, United States
Clinical Research Site #840-013
🇺🇸Bellflower, California, United States
Clinical Research Site #840-079
🇺🇸Costa Mesa, California, United States
Clinical Research Site #840-027
🇺🇸Culver City, California, United States
Clinical Research Site #840-006
🇺🇸Garden Grove, California, United States
Clinical Research Site #840-026
🇺🇸Glendale, California, United States
Clinical Research Site# 840-067
🇺🇸La Habra, California, United States
Clinical Research Site #840-035
🇺🇸Oceanside, California, United States
Clinical Research Site# 840-010
🇺🇸Panorama City, California, United States
Clinical Research Site #840-012
🇺🇸Riverside, California, United States
Clinical Research Site #840-015
🇺🇸Torrance, California, United States
Clinical Research Site #840-005
🇺🇸San Diego, California, United States
Clinical Research Site Site #840-093
🇺🇸Homestead, Florida, United States
Clinical Research Site #840-084
🇺🇸Miami Lakes, Florida, United States
Clinical Research Site #840-062
🇺🇸Lakeland, Florida, United States
Clinical Research Site #840-024
🇺🇸Largo, Florida, United States
Clinical Research Site #840-008
🇺🇸Atlanta, Georgia, United States
Clinical Research Site #840-091
🇺🇸Atlanta, Georgia, United States
Clinical Research Site # 840-102
🇺🇸Weston, Florida, United States
Clinical Research Site #840-063
🇺🇸Decatur, Georgia, United States
Clinical Research Site #840-098
🇺🇸Shreveport, Louisiana, United States
Clinical Research Site #840-057
🇺🇸Flowood, Mississippi, United States
Clinical Research Site #840-072
🇺🇸Worcester, Massachusetts, United States
Clinical Research Site #840-034
🇺🇸Saint Charles, Missouri, United States
Clinical Research Site #840-029
🇺🇸Saint Charles, Missouri, United States
Clinical Research Site #840-040
🇺🇸Olivette, Missouri, United States
Clinical Research Site #840-009
🇺🇸Jamaica, New York, United States
Clinical Research Site #840-025
🇺🇸Saint Louis, Missouri, United States
Clinical Research Site #840-070
🇺🇸New York, New York, United States
Clinical Research Site #840-061
🇺🇸Media, Pennsylvania, United States
Clinical Research Site #840-099
🇺🇸Myrtle Beach, South Carolina, United States
Clinical Research Site #840-051
🇺🇸Everett, Washington, United States
Clinical Research Site #009
🇧🇬Kazanlak, Bulgaria
Clinical Research Site #100-008
🇧🇬Novi Iskar, Bulgaria
Clinical Research Site #100-006
🇧🇬Veliko Tarnovo, Bulgaria
Clinical Research Site #100-004 2
🇧🇬Sofia, Bulgaria
Clinical Research Site #100-001
🇧🇬Vratsa, Bulgaria
Clinical Research Site #630-001
🇵🇷San Juan, Puerto Rico
Clinical Research Site # 630-002
🇵🇷San Juan, Puerto Rico
Clinical Research Site
🇵🇱Tuszyn, Woj.Iodzkie, Poland
Clinical Research Site #616-003
🇵🇱Pruszcz Gdański, Poland