A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
NCT ID: NCT01678755
Last Updated: 2021-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2012-08-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABT-126 Low Dose
ABT-126 Low Dose
ABT-126
ABT-126 Low Dose
ABT-126 High Dose
ABT-126 High Dose
ABT-126
ABT-126 High Dose
Placebo
Placebo
Placebo
Placebo
Interventions
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ABT-126
ABT-126 Low Dose
ABT-126
ABT-126 High Dose
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
20 Years
55 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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George Haig, PharmD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 74436
Chino, California, United States
Site Reference ID/Investigator# 72704
Garden Grove, California, United States
Site Reference ID/Investigator# 72699
National City, California, United States
Site Reference ID/Investigator# 73983
Oceanside, California, United States
Site Reference ID/Investigator# 73236
Orange, California, United States
Site Reference ID/Investigator# 86974
San Diego, California, United States
Site Reference ID/Investigator# 72701
Torrance, California, United States
Site Reference ID/Investigator# 75314
Bradenton, Florida, United States
Site Reference ID/Investigator# 75146
Maitland, Florida, United States
Site Reference ID/Investigator# 75654
Atlanta, Georgia, United States
Site Reference ID/Investigator# 72703
Chicago, Illinois, United States
Site Reference ID/Investigator# 76534
Hoffman Estates, Illinois, United States
Site Reference ID/Investigator# 73984
Lake Charles, Louisiana, United States
Site Reference ID/Investigator# 73981
St Louis, Missouri, United States
Site Reference ID/Investigator# 89553
Marlton, New Jersey, United States
Site Reference ID/Investigator# 72700
Cedarhurst, New York, United States
Site Reference ID/Investigator# 73982
New York, New York, United States
Site Reference ID/Investigator# 113035
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 72702
DeSoto, Texas, United States
Site Reference ID/Investigator# 75147
Houston, Texas, United States
Countries
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References
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Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Other Identifiers
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M13-608
Identifier Type: -
Identifier Source: org_study_id
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