Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Summary
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
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
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Cognitive Deficits in Schizophrenia
Intervention
ABT-288 Low Dose, Placebo, ABT-288 High Dose
Location
Site Reference ID/Investigator# 21662
Anaheim
California
United States
92804
Status
Completed
Source
AbbVie
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01077700
- Information obtained from ClinicalTrials.gov on April 25, 2013
Medical and Biotech [MESH] Definitions
Lethal Dose 50
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Mice, Inbred Sencar
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
Maximum Tolerated Dose
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Immune Tolerance
The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.
Dose Fractionation
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
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