Trials / Completed
CompletedNCT01095562
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-126 | ABT-126 Dose 1, ABT-126 Dose 2 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2011-08-01
- Completion
- 2011-09-01
- First posted
- 2010-03-30
- Last updated
- 2018-06-06
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01095562. Inclusion in this directory is not an endorsement.