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

This study is currently recruiting participants.
Verified September 2012 by Abbott
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01655680
First received: May 25, 2012
Last updated: September 19, 2012
Last verified: September 2012

May 25, 2012
September 19, 2012
May 2012
November 2013   (final data collection date for primary outcome measure)
Cognition: MCCB (MATRICS Consensus Cognitive Battery) [ Time Frame: Change from baseline to week 24 ] [ Designated as safety issue: No ]
Rater based interview
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 24 [ Time Frame: Change from baseline to week 24 ] [ Designated as safety issue: No ]
Rater based interview
Complete list of historical versions of study NCT01655680 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
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)

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: ABT-126
    ABT-126 Middle Dose
  • Drug: ABT-126
    ABT-126 Low Dose
  • Drug: ABT-126
    ABT-126 High Dose
  • Drug: Placebo
    Placebo
  • Experimental: ABT-126 Low Dose
    ABT-126 Low Dose
    Intervention: Drug: ABT-126
  • Experimental: ABT-126 Middle Dose
    ABT-126 Middle Dose
    Intervention: Drug: ABT-126
  • Experimental: ABT-126 High Dose
    ABT-126 High Dose
    Intervention: Drug: ABT-126
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
430
February 2014
November 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years to 55 Years
No
Contact: Alyssa O'Neill, BS 847-938-0387 alyssa.b.oneill@abbott.com
Contact: Catherine Kacos, BA 847-938-5613 catherine.kacos@abbott.com
United States
 
NCT01655680
M10-855, 2012-000418-13
Yes
Abbott
Abbott
 
Study Director: George Haig, PharmD Abbott
Abbott
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP