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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01077700
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : June 5, 2018
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.

Condition or disease Intervention/treatment Phase
Cognitive Deficits in Schizophrenia Drug: ABT-288 Low Dose Drug: Placebo Drug: ABT-288 High Dose Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-288 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ABT-288 Dose 1
low dose of ABT-288
Drug: ABT-288 Low Dose
Experimental: ABT-288 Dose 2
high dose of ABT-288
Drug: ABT-288 High Dose
Placebo Comparator: Sugar Pill
inactive substance
Drug: Placebo
inactive substance

Primary Outcome Measures :
  1. Cognition: MCCB [ Time Frame: Measurements from screening period through 12-week treatment period ]

Secondary Outcome Measures :
  1. Functioning: UPSA-2 [ Time Frame: Measurements from screening period through 12-week treatment period ]
  2. Cognition: CANTAB [ Time Frame: Measurements from screening period through 12-week treatment period ]
  3. Symptom Severity: PANSS, NSA-16, CGI-S [ Time Frame: Measurements from screening period through 12-week treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01077700

United States, California
Site Reference ID/Investigator# 21662
Anaheim, California, United States, 92804
Site Reference ID/Investigator# 21683
Garden Grove, California, United States, 92845
Site Reference ID/Investigator# 21581
National City, California, United States, 91950
Site Reference ID/Investigator# 45310
Norwalk, California, United States, 90650
Site Reference ID/Investigator# 26400
Pasadena, California, United States, 91106
Site Reference ID/Investigator# 21584
Pico Rivera, California, United States, 90660
Site Reference ID/Investigator# 45312
Riverside, California, United States, 92506
Site Reference ID/Investigator# 45309
San Diego, California, United States, 92128
United States, Florida
Site Reference ID/Investigator# 46603
Plantation, Florida, United States, 33317
United States, Illinois
Site Reference ID/Investigator# 21681
Chicago, Illinois, United States, 60640
United States, Louisiana
Site Reference ID/Investigator# 26397
Shreveport, Louisiana, United States, 71104-2136
United States, Massachusetts
Site Reference ID/Investigator# 21761
Pittsfield, Massachusetts, United States, 01201
United States, Missouri
Site Reference ID/Investigator# 21591
Saint Louis, Missouri, United States, 63139
United States, New York
Site Reference ID/Investigator# 26409
Brooklyn, New York, United States, 11235
Site Reference ID/Investigator# 21588
Cedarhurst, New York, United States, 11516
United States, Ohio
Site Reference ID/Investigator# 21589
Dayton, Ohio, United States, 45417
United States, Oklahoma
Site Reference ID/Investigator# 26407
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Site Reference ID/Investigator# 21601
Philadelphia, Pennsylvania, United States, 19131
United States, South Carolina
Site Reference ID/Investigator# 26399
Charleston, South Carolina, United States, 29407
United States, Texas
Site Reference ID/Investigator# 21590
Austin, Texas, United States, 78731
Site Reference ID/Investigator# 21582
Austin, Texas, United States, 78754
Site Reference ID/Investigator# 26406
DeSoto, Texas, United States, 75115
Site Reference ID/Investigator# 26402
Houston, Texas, United States, 77008
United States, Washington
Site Reference ID/Investigator# 27502
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: George Haig, PharmD AbbVie

Publications of Results:
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01077700     History of Changes
Other Study ID Numbers: M10-503
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: January 2013

Additional relevant MeSH terms:
Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders