Schizophrenia Clinical Trial
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
| Verified date | July 2023 |
| Source | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 136 |
| Est. completion date | May 23, 2023 |
| Est. primary completion date | May 23, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | 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 | |
| Hungary | Clinical Research Site #348-001 | Budapest | |
| Poland | Clinical Research Site #616-002 | Belchatów | |
| Poland | Clinical Research Site #616-003 | Pruszcz Gdanski | |
| Poland | Clinical Research Site | Tuszyn | Woj.Iodzkie |
| Puerto Rico | Clinical Research Site # 630-002 | San Juan | |
| Puerto Rico | Clinical Research Site #630-001 | San Juan | |
| United States | Clinical Research Site #840-041 | Anaheim | California |
| United States | Clinical Research Site #840-008 | Atlanta | Georgia |
| United States | Clinical Research Site #840-088 | Atlanta | Georgia |
| United States | Clinical Research Site #840-091 | Atlanta | Georgia |
| United States | Clinical Research Site #840-013 | Bellflower | California |
| United States | Clinical Research Site #840-028 | Berlin | New Jersey |
| United States | Clinical Research Site #840-074 | Charlotte | North Carolina |
| United States | Clinical Research Site | Chicago | Illinois |
| 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 #840-063 | Decatur | Georgia |
| United States | Clinical Research Site | DeSoto | Texas |
| United States | Clinical Research Site# 840-094 | Doral | Florida |
| United States | Clinical Research Site | Edmond | Oklahoma |
| United States | Clinical Research Site #840-051 | Everett | Washington |
| United States | Clinical Research Site #840-057 | Flowood | Mississippi |
| United States | Clinical Research Site #840-058 | Fort Worth | Texas |
| United States | Clinical Research Site #840-006 | Garden Grove | California |
| United States | Clinical Research Site #840-026 | Glendale | California |
| United States | Clinical Research Site #840-046 | Hollywood | Florida |
| United States | Clinical Research Site Site #840-093 | Homestead | Florida |
| United States | Clinical Research Site #840-009 | Jamaica | New York |
| United States | Clinical Research Site# 840-067 | La Habra | California |
| United States | Clinical Research Site# 840-083 | Lafayette | California |
| United States | Clinical Research Site | Lake Charles | Louisiana |
| United States | Clinical Research Site #840-062 | Lakeland | Florida |
| United States | Clinical Research Site #840-024 | Largo | Florida |
| United States | Clinical Research Site 840-002 | Lemon Grove | California |
| United States | Clinical Research Site | Little Rock | Arkansas |
| United States | Clinical Research Site #840-061 | Media | Pennsylvania |
| United States | Clinical Research Site | Memphis | Tennessee |
| 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 #840-052 | Middleburg Heights | Ohio |
| United States | Clinical Research Site #840-099 | Myrtle Beach | South Carolina |
| United States | Clinical Research Site #840-070 | New York | New York |
| United States | Clinical Research Site | Norristown | Pennsylvania |
| United States | Clinical Research Site | Oakland | California |
| United States | Clinical Research Site #840-035 | Oceanside | California |
| United States | Clinical Research Site | Okeechobee | Florida |
| United States | Clinical Research Site #840-065 | Oklahoma City | Oklahoma |
| United States | Clinical Research Site #840-040 | Olivette | Missouri |
| United States | Clinical Research Site# 840-010 | Panorama City | California |
| United States | Clinical Research Site #840-018 | Richardson | Texas |
| United States | Clinical Research Site #840-012 | Riverside | California |
| United States | Clinical Research Site | Rochester | New York |
| 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 | Saint Louis | Missouri |
| United States | Clinical Research Site #840-025 | Saint Louis | Missouri |
| United States | Clinical Research Site | San Antonio | Texas |
| 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 #840-098 | Shreveport | Louisiana |
| United States | Clinical Research Site #840-090 | Springfield | Illinois |
| United States | Clinical Research Site #840-069 | Springville | Utah |
| United States | Clinical Research Site #840-015 | Torrance | California |
| United States | Clinical Research Site # 840-102 | Weston | Florida |
| United States | Clinical Research Site #840-072 | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States, Bulgaria, Hungary, Poland, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score | Baseline; Week 15 | ||
| Secondary | Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score | Baseline; Week 15 | ||
| Secondary | Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score | Baseline; Week 15 | ||
| Secondary | Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score | Baseline; Week 15 |
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