Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Full description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-288 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-288 compared to placebo can improve cognition and what side effects ABT 288 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
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
214 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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