safety and efficacy study for cognitive deficits in adult subjects with schizophrenia

Conditions: Cognitive Deficits in Schizophrenia

Summary: this is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.

this is a phase 2 study designed to evaluate the efficacy and safety of abt-126 in approximately 210 adults with schizophrenia. subjects will be randomized to one of three treatment groups (abt-126 dose 1, abt-126 dose 2 or placebo) for a 12-week treatment period. the purpose of this research study is to find out whether abt-126 compared to placebo can improve cognition and what side effects abt-126 may cause. cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. acronyms listed in the outcomes and/or eligibility sections for this study are defined below: • mccb: measurement and treatment research to improve cognition in schizophrenia (matrics) consensus cognitive battery • upsa-2: university of california at san diego (ucsd) performance-based skills assessment-2 • cantab: cambridge neuropsychological test automated battery • panss: positive and negative syndrome scale • nsa-16: negative symptom assessment-16 • cgi-s: clinical global impression - severity

Eligibility criteria:
inclusion criteria * has current dsm-iv-tr diagnosis of schizophrenia confirmed by the mini-international neuropsychiatric interview. * is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of initial screening visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the day -1 visit; core positive symptoms of panss no worse than moderate in severity throughout screening period of at least 4 weeks. * has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit. * has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit. * has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements. exclusion criteria * has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode. * has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to screening visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to initial screening visit. * is taking any medication for extrapyramidal symptoms at any time from the initial screening visit until the day -1 visit. * is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the day -1 visit. * has significant suicidal ideation at initial screening visit. * has had a suicide attempt within 1 year prior to the day -1 visit. * has participated in another trial utilizing the matrics consensus cognitive battery (mccb) or ucsd performance-based skills assessment (upsa) (any version) within 6 months prior to initial screening visit. * is currently enrolled in any form of cognitive remediation training.