Clinical trial NCT03896945: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Negative Symptoms
Schizophrenia
AVP-786
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score
timeFrame: Baseline; Week 15
Secondary outcomes:
measure: Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score
timeFrame: Baseline; Week 15
measure: Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score
timeFrame: Baseline; Week 15
measure: Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score
timeFrame: Baseline; Week 15
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Clinical Research Site #840-041
state: California
city: Bellflower
country: United States
facility: Clinical Research Site #840-013
state: California
city: Costa Mesa
country: United States
facility: Clinical Research Site #840-079
state: California
city: Culver City
country: United States
facility: Clinical Research Site #840-027
state: California
city: Garden Grove
country: United States
facility: Clinical Research Site #840-006
state: California
city: Glendale
country: United States
facility: Clinical Research Site #840-026
state: California
city: La Habra
country: United States
facility: Clinical Research Site# 840-067
state: California
city: Lafayette
country: United States
facility: Clinical Research Site# 840-083
state: California
city: Lemon Grove
country: United States
facility: Clinical Research Site 840-002
state: California
city: Oakland
country: United States
facility: Clinical Research Site
state: California
city: Oceanside
country: United States
facility: Clinical Research Site #840-035
state: California
city: Panorama City
country: United States
facility: Clinical Research Site# 840-010
state: California
city: Riverside
country: United States
facility: Clinical Research Site #840-012
state: California
city: San Bernardino
country: United States
facility: Clinical Research Site# 840-081
state: California
city: San Diego
country: United States
facility: Clinical Research Site #840-005
state: California
city: Santee
country: United States
facility: Clinical Research Site #840-096
state: California
city: Torrance
country: United States
facility: Clinical Research Site #840-015
state: California
city: Doral
country: United States
facility: Clinical Research Site# 840-094
state: Florida
city: Hollywood
country: United States
facility: Clinical Research Site #840-046
state: Florida
city: Homestead
country: United States
facility: Clinical Research Site Site #840-093
state: Florida
city: Lakeland
country: United States
facility: Clinical Research Site #840-062
state: Florida
city: Largo
country: United States
facility: Clinical Research Site #840-024
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Research Site #840-084
state: Florida
city: Miami
country: United States
facility: Clinical Research Site #840-032
state: Florida
city: Miami
country: United States
facility: Clinical Research Site #840-080
state: Florida
city: Okeechobee
country: United States
facility: Clinical Research Site
state: Florida
city: Weston
country: United States
facility: Clinical Research Site # 840-102
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site #840-088
state: Georgia
city: Atlanta
country: United States
facility: Clinical Research Site #840-091
state: Georgia
city: Atlanta
country: United States
facility: Clinical Research Site #840-008
state: Georgia
city: Decatur
country: United States
facility: Clinical Research Site #840-063
state: Georgia
city: Chicago
country: United States
facility: Clinical Research Site
state: Illinois
city: Springfield
country: United States
facility: Clinical Research Site #840-090
state: Illinois
city: Lake Charles
country: United States
facility: Clinical Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Clinical Research Site #840-098
state: Louisiana
city: Worcester
country: United States
facility: Clinical Research Site #840-072
state: Massachusetts
city: Flowood
country: United States
facility: Clinical Research Site #840-057
state: Mississippi
city: Olivette
country: United States
facility: Clinical Research Site #840-040
state: Missouri
city: Saint Charles
country: United States
facility: Clinical Research Site #840-029
state: Missouri
city: Saint Charles
country: United States
facility: Clinical Research Site #840-034
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Site #840-025
state: Missouri
city: Berlin
country: United States
facility: Clinical Research Site #840-028
state: New Jersey
city: Jamaica
country: United States
facility: Clinical Research Site #840-009
state: New York
city: New York
country: United States
facility: Clinical Research Site #840-070
state: New York
city: Rochester
country: United States
facility: Clinical Research Site
state: New York
city: Charlotte
country: United States
facility: Clinical Research Site #840-074
state: North Carolina
city: Middleburg Heights
country: United States
facility: Clinical Research Site #840-052
state: Ohio
city: Edmond
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Clinical Research Site #840-065
state: Oklahoma
city: Media
country: United States
facility: Clinical Research Site #840-061
state: Pennsylvania
city: Norristown
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Clinical Research Site #840-099
state: South Carolina
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: DeSoto
country: United States
facility: Clinical Research Site
state: Texas
city: Fort Worth
country: United States
facility: Clinical Research Site #840-058
state: Texas
city: Richardson
country: United States
facility: Clinical Research Site #840-018
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Springville
country: United States
facility: Clinical Research Site #840-069
state: Utah
city: Everett
country: United States
facility: Clinical Research Site #840-051
state: Washington
city: Kazanlak
country: Bulgaria
facility: Clinical Research Site #009
city: Novi Iskar
country: Bulgaria
facility: Clinical Research Site #100-008
city: Plovdiv
country: Bulgaria
facility: Clinical Research Site #100-007
city: Sofia
country: Bulgaria
facility: Clinical Research Site #100-004 2
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Research Site #100-006
city: Vratsa
country: Bulgaria
facility: Clinical Research Site #100-001
city: Tuszyn
country: Poland
facility: Clinical Research Site
state: Woj.Iodzkie
city: Bełchatów
country: Poland
facility: Clinical Research Site #616-002
city: Pruszcz Gdański
country: Poland
facility: Clinical Research Site #616-003
city: San Juan
country: Puerto Rico
facility: Clinical Research Site #630-001
city: San Juan
country: Puerto Rico
facility: Clinical Research Site # 630-002
Study officials:
References: