Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia

Phase 2

Completed

• Conditions: Cognitive Deficits in Schizophrenia
• Interventions: Drug: ABT-126; Drug: Placebo

• Registration Number: NCT01095562
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-30
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Disposition First Submitted: 2012-08-30
• Disposition First Submitted QC: 2012-08-30
• Disposition First Posted: 2012-09-05
• Status Verified: 2013-01
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-126 Dose 2	ABT-126	-
ABT-126 Dose 1	ABT-126	-
Sugar Pill	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cognition: MCCB	Measurements from screening period through 12-week treatment period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Site Reference ID/Investigator# 27072; 🇺🇸 Tampa, Florida, United States

Site Reference ID/Investigator# 26264; 🇺🇸 Torrance, California, United States

Site Reference ID/Investigator# 27073; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 26268; 🇺🇸 Saint Louis, Missouri, United States

Site Reference ID/Investigator# 26388; 🇺🇸 Oceanside, California, United States

Site Reference ID/Investigator# 26392; 🇺🇸 Fresh Meadows, New York, United States

Site Reference ID/Investigator# 45315; 🇺🇸 San Bernardino, California, United States

Site Reference ID/Investigator# 26262; 🇺🇸 Rochester, New York, United States

Site Reference ID/Investigator# 27071; 🇺🇸 Beachwood, Ohio, United States

Site Reference ID/Investigator# 36020; 🇺🇸 Media, Pennsylvania, United States

Site Reference ID/Investigator# 28063; 🇺🇸 Norristown, Pennsylvania, United States

Site Reference ID/Investigator# 27069; 🇺🇸 Dallas, Texas, United States

Site Reference ID/Investigator# 27070; 🇺🇸 Sellersville, Pennsylvania, United States

Site Reference ID/Investigator# 27043; 🇺🇸 Wichita, Kansas, United States

Site Reference ID/Investigator# 26267; 🇺🇸 Cerritos, California, United States

Site Reference ID/Investigator# 45320; 🇺🇸 Costa Mesa, California, United States

Site Reference ID/Investigator# 27068; 🇺🇸 Escondido, California, United States

Site Reference ID/Investigator# 52568; 🇺🇸 Garden Grove, California, United States

Site Reference ID/Investigator# 26266; 🇺🇸 Granada Hills, California, United States

Site Reference ID/Investigator# 26271; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 27045; 🇺🇸 Santa Ana, California, United States

Site Reference ID/Investigator# 45314; 🇺🇸 Santa Ana, California, United States

Site Reference ID/Investigator# 26395; 🇺🇸 Lake Charles, Louisiana, United States