Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
NCT ID: NCT03896945
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
136 participants
INTERVENTIONAL
2019-02-15
2023-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo capsules will be administered orally twice a day over a 15-week period.
Placebo
oral capsules
AVP-786
AVP-786 capsules will be administered orally twice a day over a 15-week period.
AVP-786
oral capsules
Interventions
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Placebo
oral capsules
AVP-786
oral capsules
Eligibility Criteria
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Inclusion Criteria
* 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 pseudo-parkinsonism secondary to their ongoing antipsychotic medication
* Participants currently using anticholinergic medications
* Participants recently hospitalized as in-patients
18 Years
60 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Little Rock, Arkansas, 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# 840-083
Lafayette, California, United States
Clinical Research Site 840-002
Lemon Grove, California, United States
Clinical Research Site
Oakland, 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# 840-081
San Bernardino, California, United States
Clinical Research Site #840-005
San Diego, California, United States
Clinical Research Site #840-096
Santee, California, United States
Clinical Research Site #840-015
Torrance, California, United States
Clinical Research Site# 840-094
Doral, Florida, United States
Clinical Research Site #840-046
Hollywood, Florida, United States
Clinical Research Site Site #840-093
Homestead, Florida, United States
Clinical Research Site #840-062
Lakeland, Florida, United States
Clinical Research Site #840-024
Largo, Florida, United States
Clinical Research Site #840-032
Miami, Florida, United States
Clinical Research Site #840-080
Miami, Florida, United States
Clinical Research Site #840-084
Miami Lakes, Florida, United States
Clinical Research Site
Okeechobee, Florida, United States
Clinical Research Site # 840-102
Weston, Florida, United States
Clinical Research Site #840-088
Atlanta, Georgia, United States
Clinical Research Site #840-091
Atlanta, Georgia, United States
Clinical Research Site #840-008
Atlanta, Georgia, United States
Clinical Research Site #840-063
Decatur, Georgia, United States
Clinical Research Site
Chicago, Illinois, United States
Clinical Research Site #840-090
Springfield, Illinois, United States
Clinical Research Site
Lake Charles, Louisiana, United States
Clinical Research Site #840-098
Shreveport, Louisiana, United States
Clinical Research Site #840-072
Worcester, Massachusetts, United States
Clinical Research Site #840-057
Flowood, Mississippi, United States
Clinical Research Site #840-040
Olivette, Missouri, United States
Clinical Research Site #840-029
Saint Charles, Missouri, United States
Clinical Research Site #840-034
Saint Charles, Missouri, United States
Clinical Research Site
St Louis, Missouri, United States
Clinical Research Site #840-025
St Louis, Missouri, United States
Clinical Research Site #840-028
Berlin, New Jersey, United States
Clinical Research Site #840-009
Jamaica, New York, United States
Clinical Research Site #840-070
New York, New York, United States
Clinical Research Site
Rochester, New York, 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
Edmond, Oklahoma, United States
Clinical Research Site #840-065
Oklahoma City, Oklahoma, United States
Clinical Research Site #840-061
Media, Pennsylvania, United States
Clinical Research Site
Norristown, Pennsylvania, United States
Clinical Research Site #840-099
Myrtle Beach, South Carolina, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
DeSoto, Texas, United States
Clinical Research Site #840-058
Fort Worth, Texas, United States
Clinical Research Site #840-018
Richardson, Texas, United States
Clinical Research Site
San Antonio, Texas, United States
Clinical Research Site #840-069
Springville, Utah, 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 #100-007
Plovdiv, , Bulgaria
Clinical Research Site #100-004 2
Sofia, , Bulgaria
Clinical Research Site #100-006
Veliko Tarnovo, , Bulgaria
Clinical Research Site #100-001
Vratsa, , Bulgaria
Clinical Research Site
Tuszyn, Woj.Iodzkie, Poland
Clinical Research Site #616-002
Bełchatów, , Poland
Clinical Research Site #616-003
Pruszcz Gdański, , Poland
Clinical Research Site #630-001
San Juan, , Puerto Rico
Clinical Research Site # 630-002
San Juan, , Puerto Rico
Countries
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Other Identifiers
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2021-001352-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18-AVP-786-207
Identifier Type: -
Identifier Source: org_study_id
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