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

AbbVie (prior sponsor, Abbott)61 sites in 2 countries432 target enrollmentMay 2012

ConditionsSchizophrenia

InterventionsABT-126 Placebo

DrugsABT-126 Placebo

Overview

Phase: Phase 2
Intervention: ABT-126
Conditions: Schizophrenia
Sponsor: AbbVie (prior sponsor, Abbott)
Enrollment: 432
Locations: 61
Primary Endpoint: Cognition: MCCB (MATRICS Consensus Cognitive Battery)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

July 2014

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie (prior sponsor, Abbott)

Responsible Party

Sponsor

Eligibility 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)

Arms & Interventions

ABT-126 Low Dose

Intervention: ABT-126

ABT-126 Middle Dose

Intervention: ABT-126

ABT-126 High Dose

Intervention: ABT-126

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Cognition: MCCB (MATRICS Consensus Cognitive Battery)

Time Frame: Change from baseline to week 24

Rater based interview

Secondary Outcomes

Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)(Measurements from screening period up through week 24)
Symptom Severity: PANSS (Positive and Negative Symptom Scale)(Measurements from screening period up through week 24)
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)(Measurements from screening period up through week 24)