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
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 April 17, 2014