Safety and Efficacy 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:
NCT01095562
First received: March 26, 2010
Last updated: January 2, 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-126
Drug: Placebo
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-126 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: 207
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-126 Dose 1 Drug: ABT-126
ABT-126 Dose 1, ABT-126 Dose 2
Experimental: ABT-126 Dose 2 Drug: ABT-126
ABT-126 Dose 1, ABT-126 Dose 2
Placebo Comparator: Sugar Pill Drug: Placebo
Placebo

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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095562

Locations
United States, California
Site Reference ID/Investigator# 26267
Cerritos, California, United States, 90703
Site Reference ID/Investigator# 45320
Costa Mesa, California, United States, 92626
Site Reference ID/Investigator# 27068
Escondido, California, United States, 92025
Site Reference ID/Investigator# 52568
Garden Grove, California, United States, 92845
Site Reference ID/Investigator# 26266
Granada Hills, California, United States, 91344
Site Reference ID/Investigator# 26388
Oceanside, California, United States, 92056
Site Reference ID/Investigator# 45315
San Bernardino, California, United States, 92408
Site Reference ID/Investigator# 26271
San Diego, California, United States, 92102
Site Reference ID/Investigator# 45314
Santa Ana, California, United States, 92705
Site Reference ID/Investigator# 27045
Santa Ana, California, United States, 92701
Site Reference ID/Investigator# 26264
Torrance, California, United States, 90502
United States, Florida
Site Reference ID/Investigator# 27072
Tampa, Florida, United States, 33613
United States, Kansas
Site Reference ID/Investigator# 27043
Wichita, Kansas, United States, 67214
United States, Louisiana
Site Reference ID/Investigator# 26395
Lake Charles, Louisiana, United States, 70629
United States, Missouri
Site Reference ID/Investigator# 26268
St. Louis, Missouri, United States, 63118
United States, New York
Site Reference ID/Investigator# 26392
Fresh Meadows, New York, United States, 11366
Site Reference ID/Investigator# 27073
New York, New York, United States, 10065
Site Reference ID/Investigator# 26262
Rochester, New York, United States, 14618
United States, Ohio
Site Reference ID/Investigator# 27071
Beachwood, Ohio, United States, 44122
United States, Pennsylvania
Site Reference ID/Investigator# 36020
Media, Pennsylvania, United States, 19063
Site Reference ID/Investigator# 28063
Norristown, Pennsylvania, United States, 19401
Site Reference ID/Investigator# 27070
Sellersville, Pennsylvania, United States, 18960
United States, Texas
Site Reference ID/Investigator# 27069
Dallas, Texas, United States, 75243
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: NCT01095562     History of Changes
Other Study ID Numbers: M10-854
Study First Received: March 26, 2010
Last Updated: January 2, 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 April 16, 2014