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This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study, evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia who are experiencing an acute psychotic episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP-104 | Drug | 200 mg, tablet, BID, 6 weeks |
| |
| ACP-104 |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
In addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92805 | United States | |||
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| Drug |
100 mg, tablet, BID, 6 weeks |
|
| Placebo | Drug | placebo, tablet BID, 6 weeks |
|
| Costa Mesa |
| California |
| 92626 |
| United States |
| Covina | California | 91724 | United States |
| Culver City | California | 90232 | United States |
| Garden Grove | California | 92845 | United States |
| Glendale | California | 91206 | United States |
| Huntington Beach | California | 92647 | United States |
| Oceanside | California | 92056 | United States |
| Paramount | California | 90723 | United States |
| Pasadena | California | 91107 | United States |
| Pico Rivera | California | 90660 | United States |
| Riverside | California | 92506 | United States |
| San Diego | California | 92108 | United States |
| Bradenton | Florida | 34208 | United States |
| Kissimmee | Florida | 34741 | United States |
| Atlanta | Georgia | 30308 | United States |
| Baltimore | Maryland | 21202 | United States |
| St Louis | Missouri | 63118 | United States |
| Willingboro | New Jersey | 08046 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Austin | Texas | 78754 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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