A 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:
NCT01655680
First received: May 25, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This is a safety and 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, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Cognition: MCCB (MATRICS Consensus Cognitive Battery) [ Time Frame: Change from baseline to week 24 ] [ 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 24 ] [ Designated as safety issue: No ]
    Rater based interview

  • Symptom Severity: PANSS (Positive and Negative Symptom Scale) [ Time Frame: Measurements from screening period up through week 24 ] [ 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 24 ] [ Designated as safety issue: No ]
    Rater based interview


Enrollment: 432
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: July 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 Middle Dose
ABT-126 Middle Dose
Drug: ABT-126
ABT-126 Middle 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:

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

  Eligibility

Ages Eligible for Study:   20 Years to 65 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: NCT01655680

  Show 61 Study Locations
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: NCT01655680     History of Changes
Other Study ID Numbers: M10-855, 2012-000418-13
Study First Received: May 25, 2012
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:
Schizophrenia

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

ClinicalTrials.gov processed this record on August 21, 2014