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The objective of this study is to explore the safety and efficacy of ABT-925 involving patients who meet the DSM-IV-TR (Diagnostic and Statistical Manual of Medical Disorders, Fourth Edition Text Revision) criteria for an acute exacerbation of schizophrenia or schizoaffective disorder.
To explore the safety and efficacy of ABT-925 treatment at three different doses for 6 weeks compared with placebo in subjects with a diagnosis of acute exacerbation of schizophrenia or schizoaffective disorder according to DSM-IV-TR criteria (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator |
| |
| Group 1 Part 1 - ABT-925 | Experimental |
| |
| Group 1 Part 2 - ABT-925 | Experimental |
| |
| Group 2 - ABT-925 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-925 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Positive and Negative Syndrome Scale | The PANSS (The Positive and Negative Syndrome Scale) assesses the severity of symptoms of schizophrenia over the preceding seven days. The PANSS items are divided into positive, negative, and general psychopathology factors. The PANSS total score is the score of all 30 PANSS items taken together. | Assessed at screening and weekly from baseline through week 42/premature discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Psychiatric Rating Scale | Subscale of PANSS (The Positive and Negative Syndrome Scale) | Assessed at screening and weekly from baseline through week 42/premature discontinuation |
| Clinical Global Impression Severity score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Rendenbach-Mueller, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 5188 | Anaheim | California | 92805 | United States | ||
| Site Reference ID/Investigator# 4539 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21346607 | Derived | Redden L, Rendenbach-Mueller B, Abi-Saab WM, Katz DA, Goenjian A, Robieson WZ, Wang Y, Goss SL, Greco N 4th, Saltarelli MD. A double-blind, randomized, placebo-controlled study of the dopamine D(3) receptor antagonist ABT-925 in patients with acute schizophrenia. J Clin Psychopharmacol. 2011 Apr;31(2):221-5. doi: 10.1097/JCP.0b013e31820e4818. |
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| Drug |
|
Assesses the overall, absolute degree of illness at any point in time (refer to the degree of illness at the time of the visit and during the week prior to the visit).
| Assessed at screening and weekly from baseline through week 42/premature discontinuation |
| Calgary Depression Scale for Schizophrenia Total score | The CDSS (Calgary Depression Scale for Schizophrenia Total score) consists of items designed to assess the severity of symptoms of depression in the presence of schizophrenia such as depressed mood, hopelessness, guilt, and insomnia. | Assessed at screening and weekly from baseline through week 42/premature discontinuation |
| Negative Symptom Assessment | The NSA (Negative Symptom Assessment) is a 16-item instrument plus a one-item global rating designed to measure specific negative symptoms in schizophrenia | Assessed at screening and weekly from baseline through week 42/premature discontinuation |
| Cerritos |
| California |
| 90703 |
| United States |
| Site Reference ID/Investigator# 4175 | Garden Grove | California | 92845 | United States |
| Site Reference ID/Investigator# 4553 | Pico Rivera | California | 90660 | United States |
| Site Reference ID/Investigator# 4173 | San Diego | California | 92126 | United States |
| Site Reference ID/Investigator# 4565 | Upland | California | 91786 | United States |
| Site Reference ID/Investigator# 4177 | North Miami | Florida | 33161 | United States |
| Site Reference ID/Investigator# 4168 | Atlanta | Georgia | 30308 | United States |
| Site Reference ID/Investigator# 4567 | Austin | Texas | 78754 | United States |
| Site Reference ID/Investigator# 4176 | Austin | Texas | 78756 | United States |
| Site Reference ID/Investigator# 4371 | Bellaire | Texas | 77401 | United States |
| Site Reference ID/Investigator# 5227 | Buenos Aires | CP1425 | Argentina |
| Site Reference ID/Investigator# 5226 | Córdoba | X5009BIN | Argentina |
| Site Reference ID/Investigator# 5224 | La Plata | 1900 | Argentina |
| Site Reference ID/Investigator# 4305 | Guadalajara | 44280 | Mexico |
| Site Reference ID/Investigator# 4304 | Mexico City | CP 03740 | Mexico |
| Site Reference ID/Investigator# 4303 | Mexico City | CP 14000 | Mexico |
| Site Reference ID/Investigator# 4298 | Monterrey | CP 64000 | Mexico |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C585125 | ABT-925 |
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