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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:20 - 65
Updated:1/1/2014
Start Date:May 2012
End Date:July 2014
Contact:Alyssa O'Neill, BS
Email:alyssa.b.oneill@abbvie.com
Phone:847-938-0387

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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)

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

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.

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)
We found this trial at
33
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1944
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Oceanside, CA
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1962
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Anaheim, CA
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436
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Atlanta, GA
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491
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Cedarhurst, NY
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274
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Chicago, IL
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Chino, CA
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Costa Mesa, CA
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Dallas, TX
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Desoto, TX
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1935
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Escondido, CA
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1963
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Garden Grove, CA
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991
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Houston, TX
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991
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Houston, TX
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La Habra, CA
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Marietta, GA
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National City, California 91950
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National City, CA
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New Haven, CT
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Norwalk, CA
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Oakland, CA
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Orange, CA
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Paramount, CA
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Pasadena, CA
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Philadelphia, PA
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1965
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Pico Rivera, CA
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1935
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Riverside, CA
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355
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Rochester, NY
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San Bernardino, California 92408
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San Bernardino, CA
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1951
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San Diego, CA
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1951
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Santa Ana, CA
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Staten Island, NY
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1983
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Torrance, CA
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784
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Wichita, KS
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