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

Phase 2

Completed

Conditions: Schizophrenia

Interventions: Drug: ABT-126
Drug: Placebo

Registration Number: NCT01655680

Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 432

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-126 Middle Dose	ABT-126	ABT-126 Middle Dose
ABT-126 High Dose	ABT-126	ABT-126 High Dose
Placebo	Placebo	Placebo
ABT-126 Low Dose	ABT-126	ABT-126 Low Dose

Primary Outcome Measures

Name	Time	Method
Cognition: MCCB (MATRICS Consensus Cognitive Battery)	Change from baseline to week 24	Rater based interview

Secondary Outcome Measures

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

Trial Locations

Locations (61): Site Reference ID/Investigator# 75136
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New Haven, Connecticut, United States
Site Reference ID/Investigator# 94476
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Chita, Russian Federation
Site Reference ID/Investigator# 81934
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Moscow, Russian Federation
Site Reference ID/Investigator# 97135
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 84733
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 79520
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Stavropol, Russian Federation
Site Reference ID/Investigator# 75140
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San Diego, California, United States
Site Reference ID/Investigator# 74433
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Santa Ana, California, United States
Site Reference ID/Investigator# 72695
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Torrance, California, United States
Site Reference ID/Investigator# 75139
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Anaheim, California, United States
Site Reference ID/Investigator# 76593
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Costa Mesa, California, United States
Site Reference ID/Investigator# 72697
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Chicago, Illinois, United States
Site Reference ID/Investigator# 75053
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Staten Island, New York, United States
Site Reference ID/Investigator# 74896
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Houston, Texas, United States
Site Reference ID/Investigator# 72694
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Cedarhurst, New York, United States
Site Reference ID/Investigator# 94528
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Kazan, Russian Federation
Site Reference ID/Investigator# 79516
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Moscow, Russian Federation
Site Reference ID/Investigator# 79517
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Lipetsk, Russian Federation
Site Reference ID/Investigator# 81938
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Brentford, United Kingdom
Site Reference ID/Investigator# 92813
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London, United Kingdom
Site Reference ID/Investigator# 81939
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London, United Kingdom
Site Reference ID/Investigator# 81943
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Oxford, United Kingdom
Site Reference ID/Investigator# 82238
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Preston, United Kingdom
Site Reference ID/Investigator# 83116
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Novosibirsk, Russian Federation
Site Reference ID/Investigator# 97136
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Saint-Petersburg, Russian Federation
Site Reference ID/Investigator# 72696
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DeSoto, Texas, United States
Site Reference ID/Investigator# 74893
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Marietta, Georgia, United States
Site Reference ID/Investigator# 74553
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Dallas, Texas, United States
Site Reference ID/Investigator# 76533
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Hoffman Estates, Illinois, United States
Site Reference ID/Investigator# 79515
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Ekaterinburg, Russian Federation
Site Reference ID/Investigator# 81935
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Moscow, Russian Federation
Site Reference ID/Investigator# 81933
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Saratov, Russian Federation
Site Reference ID/Investigator# 79514
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Saratov, Russian Federation
Site Reference ID/Investigator# 85093
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 83117
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Yaroslavl, Russian Federation
Site Reference ID/Investigator# 97138
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Yekaterinburg, Russian Federation
Site Reference ID/Investigator# 81940
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Edinburgh, United Kingdom
Site Reference ID/Investigator# 97137
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 83115
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 81937
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Newcastle upon Tyne, United Kingdom
Site Reference ID/Investigator# 73213
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Escondido, California, United States
Site Reference ID/Investigator# 72693
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National City, California, United States
Site Reference ID/Investigator# 74434
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Chino, California, United States
Site Reference ID/Investigator# 75057
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La Habra, California, United States
Site Reference ID/Investigator# 74894
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Bellflower, California, United States
Site Reference ID/Investigator# 77655
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Norwalk, California, United States
Site Reference ID/Investigator# 74895
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Oakland, California, United States
Site Reference ID/Investigator# 80673
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 75056
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Wichita, Kansas, United States
Site Reference ID/Investigator# 74453
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Pico Rivera, California, United States
Site Reference ID/Investigator# 75137
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Rochester, New York, United States
Site Reference ID/Investigator# 86973
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San Diego, California, United States
Site Reference ID/Investigator# 72698
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Garden Grove, California, United States
Site Reference ID/Investigator# 74898
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Riverside, California, United States
Site Reference ID/Investigator# 98016
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San Bernardino, California, United States
Site Reference ID/Investigator# 75413
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Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 75055
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Houston, Texas, United States
Site Reference ID/Investigator# 73977
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Oceanside, California, United States
Site Reference ID/Investigator# 73214
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Orange, California, United States
Site Reference ID/Investigator# 73974
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San Gabriel, California, United States
Site Reference ID/Investigator# 75653
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Atlanta, Georgia, United States