Trials / Completed
CompletedNCT01077700
Efficacy and Safety 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-288 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 214 (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-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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-288 Low Dose | |
| DRUG | Placebo | inactive substance |
| DRUG | ABT-288 High Dose |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2010-03-01
- Last updated
- 2018-06-06
Locations
24 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01077700. Inclusion in this directory is not an endorsement.