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

February 26, 2010
March 29, 2013
March 2010
July 2011   (final data collection date for primary outcome measure)
Cognition: MCCB [ Time Frame: Measurements from screening period through 12-week treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01077700 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
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)

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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cognitive Deficits in Schizophrenia
  • Drug: ABT-288 Low Dose
  • Drug: Placebo
    inactive substance
  • Drug: ABT-288 High Dose
  • Experimental: ABT-288 Dose 1
    low dose of ABT-288
    Intervention: Drug: ABT-288 Low Dose
  • Experimental: ABT-288 Dose 2
    high dose of ABT-288
    Intervention: Drug: ABT-288 High Dose
  • Placebo Comparator: Sugar Pill
    inactive substance
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01077700
M10-503
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: George Haig, PharmD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP