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A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in 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.
 
ClinicalTrials.gov Identifier: NCT01678755
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12 [ Time Frame: Change from baseline to week 12 ]
Rater based interview
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 24 [ Time Frame: Change from baseline to week 12 ]
Rater based interview
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) [ Time Frame: Measurements from screening period up through week 12 ]
    Rater based interview
  • Symptom Severity: PANSS (Positive and Negative Syndrome Scale) [ Time Frame: Measurements from screening period up through week 12 ]
    Rater based interview
  • Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) [ Time Frame: Measurements from screening period up through week 12 ]
    Rater based interview
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers
Brief Summary This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed Description Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: ABT-126
    ABT-126 Low Dose
  • Drug: ABT-126
    ABT-126 High Dose
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: ABT-126 Low Dose
    ABT-126 Low Dose
    Intervention: Drug: ABT-126
  • Experimental: ABT-126 High Dose
    ABT-126 High Dose
    Intervention: Drug: ABT-126
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
157
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2012)
150
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
  • Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (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 contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion Criteria:

  • In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
  • Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
  • Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
  • Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
  • Has any risk factors for Torsades de Pointes (TdP)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678755
Other Study ID Numbers  ICMJE M13-608
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: George Haig, PharmD AbbVie
PRS Account AbbVie
Verification Date March 2015

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