Skip to main content
Clinical Trials/NCT01095562
NCT01095562
Completed
Phase 2

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)

AbbVie (prior sponsor, Abbott)23 sites in 1 country207 target enrollmentMarch 2010

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

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
September 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (23)

Loading locations...

Similar Trials