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

NCT ID: NCT01095562

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-09-30

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

Conditions

Cognitive Deficits in Schizophrenia

Study Design

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

Study Groups

ABT-126 Dose 1

Group Type: EXPERIMENTAL

ABT-126

Intervention Type: DRUG

ABT-126 Dose 1, ABT-126 Dose 2

ABT-126 Dose 2

Group Type: EXPERIMENTAL

ABT-126

Intervention Type: DRUG

ABT-126 Dose 1, ABT-126 Dose 2

Sugar Pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

ABT-126

ABT-126 Dose 1, ABT-126 Dose 2

Intervention Type: DRUG

Placebo

Placebo

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# 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# 26388

Oceanside, California, United States

Site Reference ID/Investigator# 45315

San Bernardino, 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# 26264

Torrance, California, United States

Site Reference ID/Investigator# 27072

Tampa, Florida, United States

Site Reference ID/Investigator# 27043

Wichita, Kansas, United States

Site Reference ID/Investigator# 26395

Lake Charles, Louisiana, United States

Site Reference ID/Investigator# 26268

St Louis, Missouri, United States

Site Reference ID/Investigator# 26392

Fresh Meadows, New York, United States

Site Reference ID/Investigator# 27073

New York, New York, 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# 27070

Sellersville, Pennsylvania, United States

Site Reference ID/Investigator# 27069

Dallas, Texas, United States

Countries

United States

References

Hashimoto K. Targeting of alpha7 Nicotinic Acetylcholine Receptors in the Treatment of Schizophrenia and the Use of Auditory Sensory Gating as a Translational Biomarker. Curr Pharm Des. 2015;21(26):3797-806. doi: 10.2174/1381612821666150605111345.

Reference Type: BACKGROUND

PMID: 26044974 (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

M10-854

Identifier Type: -

Identifier Source: org_study_id