Trial Title: An Evaluation of the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia
Trial Therapeutic Area: CNS
Trial Country Location(s): Global
Trial Patient Population:
18 Years - 65 Years, Genders Eligible for Study: Both
Investigator Requirments:
Trial Inclusion/Exclusion Criteria:
Inclusion
- The subject has a current primary diagnosis of schizophrenia or schizoaffective disorder; specifically, an acute exacerbation with prominent "active phase" symptoms, as described in DSM-IV-TR criteria (and confirmed by the SCID I/P). Subjects with schizophrenia may belong to any of the following subtypes: paranoid, disorganized, catatonic, or undifferentiated
- The subject has a PANSS total score of >= 60
- The subject has a score of >= 4 ("moderate") on at least 2 out of the following 5 PANSS positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution
Exclusion
- The subject has any condition that is likely to interfere with his/her ability to complete the study and all the study-related procedures (e.g., blindness, deafness, language difficulties, sensory or motor deficits)
- The subject has any condition which is likely to interfere significantly with the absorption, distribution, metabolism or excretion of the active treatment, including: malabsorption syndromes, previous GI surgery, active peptic ulcer disease, chronic GI disease etc.; evidence suggesting impaired kidney function (e.g., raised urea or creatinine with albuminuria or hematuria); any condition affecting plasma proteins (e.g., multiple myeloma, chronic medical illness)
Person of Contact Info:
Jeanne Martin
Phone: 847-938-7814