A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01678755
First received: August 31, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
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)
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) in Smokers

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12 [ Time Frame: Change from baseline to week 12 ] [ Designated as safety issue: No ]
    Rater based interview


Secondary Outcome Measures:
  • Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) [ Time Frame: Measurements from screening period up through week 12 ] [ Designated as safety issue: No ]
    Rater based interview

  • Symptom Severity: PANSS (Positive and Negative Syndrome Scale) [ Time Frame: Measurements from screening period up through week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Rater based interview


Enrollment: 156
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-126 Low Dose
ABT-126 Low Dose
Drug: ABT-126
ABT-126 Low Dose
Experimental: ABT-126 High Dose
ABT-126 High Dose
Drug: ABT-126
ABT-126 High Dose
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Detailed Description:

Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01678755

Locations
United States, California
Site Reference ID/Investigator# 74436
Chino, California, United States, 91710
Site Reference ID/Investigator# 72704
Garden Grove, California, United States, 92845
Site Reference ID/Investigator# 72699
National City, California, United States, 91950
Site Reference ID/Investigator# 73983
Oceanside, California, United States, 92056
Site Reference ID/Investigator# 73236
Orange, California, United States, 92868
Site Reference ID/Investigator# 86974
San Diego, California, United States, 92102
Site Reference ID/Investigator# 72701
Torrance, California, United States, 90502
United States, Florida
Site Reference ID/Investigator# 75314
Bradenton, Florida, United States, 34208
Site Reference ID/Investigator# 75146
Maitland, Florida, United States, 32751
United States, Georgia
Site Reference ID/Investigator# 75654
Atlanta, Georgia, United States, 30308
United States, Illinois
Site Reference ID/Investigator# 72703
Chicago, Illinois, United States, 60640
Site Reference ID/Investigator# 76534
Hoffman Estates, Illinois, United States, 60169
United States, Louisiana
Site Reference ID/Investigator# 73984
Lake Charles, Louisiana, United States, 70629
United States, Missouri
Site Reference ID/Investigator# 73981
St. Louis, Missouri, United States, 63109
United States, New Jersey
Site Reference ID/Investigator# 89553
Marlton, New Jersey, United States, 08053
United States, New York
Site Reference ID/Investigator# 72700
Cedarhurst, New York, United States, 11516
Site Reference ID/Investigator# 73982
New York, New York, United States, 10065
United States, Oklahoma
Site Reference ID/Investigator# 113035
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
Site Reference ID/Investigator# 72702
DeSoto, Texas, United States, 75115
Site Reference ID/Investigator# 75147
Houston, Texas, United States, 77008
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: NCT01678755     History of Changes
Other Study ID Numbers: M13-608
Study First Received: August 31, 2012
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
schizophrenia

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

ClinicalTrials.gov processed this record on July 20, 2014