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

NCT ID: NCT01077700

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-07-31

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

Conditions

Cognitive Deficits in Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ABT-288 Dose 1

low dose of ABT-288

Group Type: EXPERIMENTAL

ABT-288 Low Dose

Intervention Type: DRUG

ABT-288 Dose 2

high dose of ABT-288

Group Type: EXPERIMENTAL

ABT-288 High Dose

Intervention Type: DRUG

Sugar Pill

inactive substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

inactive substance

Interventions

ABT-288 Low Dose

Intervention Type: DRUG

Placebo

inactive substance

Intervention Type: DRUG

ABT-288 High Dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Haig, PharmD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 21662

Anaheim, California, United States

Site Reference ID/Investigator# 21683

Garden Grove, California, United States

Site Reference ID/Investigator# 21581

National City, California, United States

Site Reference ID/Investigator# 45310

Norwalk, California, United States

Site Reference ID/Investigator# 26400

Pasadena, California, United States

Site Reference ID/Investigator# 21584

Pico Rivera, California, United States

Site Reference ID/Investigator# 45312

Riverside, California, United States

Site Reference ID/Investigator# 45309

San Diego, California, United States

Site Reference ID/Investigator# 46603

Plantation, Florida, United States

Site Reference ID/Investigator# 21681

Chicago, Illinois, United States

Site Reference ID/Investigator# 26397

Shreveport, Louisiana, United States

Site Reference ID/Investigator# 21761

Pittsfield, Massachusetts, United States

Site Reference ID/Investigator# 21591

St Louis, Missouri, United States

Site Reference ID/Investigator# 26409

Brooklyn, New York, United States

Site Reference ID/Investigator# 21588

Cedarhurst, New York, United States

Site Reference ID/Investigator# 21589

Dayton, Ohio, United States

Site Reference ID/Investigator# 26407

Oklahoma City, Oklahoma, 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# 21590

Austin, Texas, United States

Site Reference ID/Investigator# 21582

Austin, Texas, 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

Countries

United States

References

Haig GM, Bain E, Robieson W, Othman AA, Baker J, Lenz RA. A randomized trial of the efficacy and safety of the H3 antagonist ABT-288 in cognitive impairment associated with schizophrenia. Schizophr Bull. 2014 Nov;40(6):1433-42. doi: 10.1093/schbul/sbt240. Epub 2014 Feb 10.

Reference Type: RESULT

PMID: 24516190 (View on PubMed)

Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

Reference Type: DERIVED

PMID: 28433500 (View on PubMed)

Other Identifiers

M10-503

Identifier Type: -

Identifier Source: org_study_id