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
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: 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 September 16, 2014