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

Phase 2

Completed

• Conditions: Cognitive Deficits in Schizophrenia
• Interventions: Drug: ABT-288 High Dose; Drug: Placebo; Drug: ABT-288 Low Dose

• Registration Number: NCT01077700
• 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-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

Study Timeline

• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study Start: 2010-03
• Study First Posted: 2010-03-01
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Disposition First Submitted: 2012-07-12
• Disposition First Submitted QC: 2012-07-12
• Disposition First Posted: 2012-07-23
• Status Verified: 2013-01
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview.
• Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day -1 visit; core positive symptoms of PANSS no worse than moderate in severity throughout Screening Period of at least 4 weeks.
• Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Initial Screening Visit.
• Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to Initial Screening Visit.
• Has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements.

Exclusion Criteria

• Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode.
• Has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to Screening Visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to Initial Screening Visit.
• Is taking any medication for extrapyramidal symptoms at any time from the Initial Screening Visit until the Day -1 Visit.
• Is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit.
• Has significant suicidal ideation at Initial Screening Visit.
• Has had a suicide attempt within 1 year prior to the Day -1 Visit.
• Has participated in another trial utilizing the MATRICS Consensus Cognitive Battery (MCCB) or UCSD Performance-Based Skills Assessment (UPSA) (any version) within 6 months prior to Initial Screening Visit.
• Is currently enrolled in any form of cognitive remediation training.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-288 Dose 2	ABT-288 High Dose	high dose of ABT-288
Sugar Pill	Placebo	inactive substance
ABT-288 Dose 1	ABT-288 Low Dose	low dose of ABT-288

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 (24)

Site Reference ID/Investigator# 21584; 🇺🇸 Pico Rivera, California, United States

Site Reference ID/Investigator# 21681; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 45310; 🇺🇸 Norwalk, California, United States

Site Reference ID/Investigator# 21662; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 21588; 🇺🇸 Cedarhurst, New York, United States

Site Reference ID/Investigator# 45309; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 21590; 🇺🇸 Austin, Texas, United States

Site Reference ID/Investigator# 21582; 🇺🇸 Austin, Texas, United States

Site Reference ID/Investigator# 46603; 🇺🇸 Plantation, Florida, United States

Site Reference ID/Investigator# 21591; 🇺🇸 Saint Louis, Missouri, United States

Site Reference ID/Investigator# 21581; 🇺🇸 National City, California, United States

Site Reference ID/Investigator# 26397; 🇺🇸 Shreveport, Louisiana, United States

Site Reference ID/Investigator# 26400; 🇺🇸 Pasadena, California, United States

Site Reference ID/Investigator# 26407; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Reference ID/Investigator# 21761; 🇺🇸 Pittsfield, Massachusetts, United States

Site Reference ID/Investigator# 21683; 🇺🇸 Garden Grove, California, United States

Site Reference ID/Investigator# 45312; 🇺🇸 Riverside, California, United States

Site Reference ID/Investigator# 26409; 🇺🇸 Brooklyn, New York, United States

Site Reference ID/Investigator# 21589; 🇺🇸 Dayton, Ohio, United States

Site Reference ID/Investigator# 21601; 🇺🇸 Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 26399; 🇺🇸 Charleston, South Carolina, United States

Site Reference ID/Investigator# 26406; 🇺🇸 DeSoto, Texas, United States

Site Reference ID/Investigator# 26402; 🇺🇸 Houston, Texas, United States

Site Reference ID/Investigator# 27502; 🇺🇸 Bellevue, Washington, United States