A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Cognitive Deficits in Schizophrenia
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 207
- Locations
- 23
- Primary Endpoint
- Cognition: MCCB
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sugar Pill
Intervention: Placebo
ABT-126 Dose 1
Intervention: ABT-126
ABT-126 Dose 2
Intervention: ABT-126
Outcomes
Primary Outcomes
Cognition: MCCB
Time Frame: Measurements from screening period through 12-week treatment period
Secondary Outcomes
- Functioning: UPSA-2(Measurements from screening period through 12-week treatment period)
- Symptom Severity: PANSS, NSA-16, CGI-S(Measurements from screening period through 12-week treatment period)
- Cognition: CANTAB(Measurements from screening period through 12-week treatment period)