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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ABT-126
* Drug: ABT-126
* Drug: ABT-126
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-126 Low Dose<br>ABT-126 Low Dose | Drug: ABT-126<br>* ABT-126 Low Dose<br>|
| Experimental: ABT-126 Middle Dose<br>ABT-126 Middle Dose | Drug: ABT-126<br>* ABT-126 Middle Dose<br>|
| Experimental: ABT-126 High Dose<br>ABT-126 High Dose | Drug: ABT-126<br>* ABT-126 High Dose<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition: MCCB (MATRICS Consensus Cognitive Battery) | Rater based interview | Change from baseline to week 24 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia