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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.
This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.
Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP-6124 0.3 mg | Active Comparator | one 0.3 mg capsule every day for 84 days |
|
| EVP-6124 1.0 mg | Active Comparator | one 1.0 mg capsule every day for 84 days. |
|
| Placebo | Placebo Comparator | Placebo every day for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP-6124 | Drug | Arms: 1 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function. | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Clinical Efficacy | 84 days |
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Inclusion Criteria:
Exclusion Criteria:
General
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| Name | Affiliation | Role |
|---|---|---|
| Chris Southard | Syneos Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intergrated Medical and Behavioral Associates | Glendale | California | 91204 | United States | ||
| Excell Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28433500 | Derived | Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20. |
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| Drug |
Arm: 3 |
|
| EVP-6124 | Drug | Arms: 2 |
|
| Oceanside |
| California |
| 92056 |
| United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | United States |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| Alexian Brothers Behavioral Health | Hoffman Estates | Illinois | 60169 | United States |
| CBH Health, LLC | Rockville | Maryland | 20850 | United States |
| CRI Worldwide | Willingboro | New Jersey | 20850 | United States |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | United States |
| Vanderbilt Psychiatric Hospital | Nashville | Tennessee | 37212-8645 | United States |
| FutureSearch Clinical Trials, L.P. | Austin | Texas | 78756 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Arkhangelsk | 163530 | Russia |
| Kazan' | 420012 | Russia |
| Moscow | 107076 | Russia |
| Moscow | 115522 | Russia |
| Saint Petersburg | 190121 | Russia |
| Stavropol | 355108 | Russia |
| Clinical Site 1 | Belgrade | 11000 | Serbia |
| Clinical Site 2 | Belgrade | 11000 | Serbia |
| Clinical Site 3 | Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Niš | 18000 | Serbia |
| Crimea | 95006 | Ukraine |
| Dnipro | 49005 | Ukraine |
| Kiev | 02660 | Ukraine |
| Kiev | 04080 | Ukraine |
| Odesa | 65014 | Ukraine |
| Vinnytsia | 21005 | Ukraine |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C573817 | 7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide |
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