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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077700
First received: February 26, 2010
Last updated: March 29, 2013
Last verified: January 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Cognition: MCCB [ Time Frame: Measurements from screening period through 12-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functioning: UPSA-2 [ Time Frame: Measurements from screening period through 12-week treatment period ] [ Designated as safety issue: No ]
  • Cognition: CANTAB [ Time Frame: Measurements from screening period through 12-week treatment period ] [ Designated as safety issue: No ]
  • Symptom Severity: PANSS, NSA-16, CGI-S [ Time Frame: Measurements from screening period through 12-week treatment period ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077700

Locations
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
St. 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# 21582
Austin, Texas, United States, 78754
Site Reference ID/Investigator# 21590
Austin, Texas, United States, 78731
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)
Investigators
Study Director: George Haig, PharmD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077700     History of Changes
Other Study ID Numbers: M10-503
Study First Received: February 26, 2010
Last Updated: March 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014