A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
NCT ID: NCT01655680
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
432 participants
INTERVENTIONAL
2012-05-31
2014-07-31
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 Middle Dose
ABT-126 Middle Dose
ABT-126
ABT-126 Middle 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 Middle Dose
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
65 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# 75139
Anaheim, California, United States
Site Reference ID/Investigator# 74894
Bellflower, California, United States
Site Reference ID/Investigator# 74434
Chino, California, United States
Site Reference ID/Investigator# 76593
Costa Mesa, California, United States
Site Reference ID/Investigator# 73213
Escondido, California, United States
Site Reference ID/Investigator# 72698
Garden Grove, California, United States
Site Reference ID/Investigator# 75057
La Habra, California, United States
Site Reference ID/Investigator# 72693
National City, California, United States
Site Reference ID/Investigator# 77655
Norwalk, California, United States
Site Reference ID/Investigator# 74895
Oakland, California, United States
Site Reference ID/Investigator# 73977
Oceanside, California, United States
Site Reference ID/Investigator# 73214
Orange, California, United States
Site Reference ID/Investigator# 74453
Pico Rivera, California, United States
Site Reference ID/Investigator# 74898
Riverside, California, United States
Site Reference ID/Investigator# 98016
San Bernardino, California, United States
Site Reference ID/Investigator# 86973
San Diego, California, United States
Site Reference ID/Investigator# 75140
San Diego, California, United States
Site Reference ID/Investigator# 73974
San Gabriel, California, United States
Site Reference ID/Investigator# 74433
Santa Ana, California, United States
Site Reference ID/Investigator# 72695
Torrance, California, United States
Site Reference ID/Investigator# 75136
New Haven, Connecticut, United States
Site Reference ID/Investigator# 75653
Atlanta, Georgia, United States
Site Reference ID/Investigator# 74893
Marietta, Georgia, United States
Site Reference ID/Investigator# 72697
Chicago, Illinois, United States
Site Reference ID/Investigator# 76533
Hoffman Estates, Illinois, United States
Site Reference ID/Investigator# 75056
Wichita, Kansas, United States
Site Reference ID/Investigator# 72694
Cedarhurst, New York, United States
Site Reference ID/Investigator# 75137
Rochester, New York, United States
Site Reference ID/Investigator# 75053
Staten Island, New York, United States
Site Reference ID/Investigator# 75413
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 74553
Dallas, Texas, United States
Site Reference ID/Investigator# 72696
DeSoto, Texas, United States
Site Reference ID/Investigator# 75055
Houston, Texas, United States
Site Reference ID/Investigator# 74896
Houston, Texas, United States
Site Reference ID/Investigator# 94476
Chita, , Russia
Site Reference ID/Investigator# 94528
Kazan', , Russia
Site Reference ID/Investigator# 79517
Lipetsk, , Russia
Site Reference ID/Investigator# 81934
Moscow, , Russia
Site Reference ID/Investigator# 81935
Moscow, , Russia
Site Reference ID/Investigator# 79516
Moscow, , Russia
Site Reference ID/Investigator# 83116
Novosibirsk, , Russia
Site Reference ID/Investigator# 80673
Saint Petersburg, , Russia
Site Reference ID/Investigator# 85093
Saint Petersburg, , Russia
Site Reference ID/Investigator# 97135
Saint Petersburg, , Russia
Site Reference ID/Investigator# 97137
Saint Petersburg, , Russia
Site Reference ID/Investigator# 83115
Saint Petersburg, , Russia
Site Reference ID/Investigator# 97136
Saint Petersburg, , Russia
Site Reference ID/Investigator# 84733
Saint Petersburg, , Russia
Site Reference ID/Investigator# 81933
Saratov, , Russia
Site Reference ID/Investigator# 79514
Saratov, , Russia
Site Reference ID/Investigator# 79520
Stavropol, , Russia
Site Reference ID/Investigator# 83117
Yaroslavl, , Russia
Site Reference ID/Investigator# 97138
Yekaterinburg, , Russia
Site Reference ID/Investigator# 79515
Yekaterinburg, , Russia
Site Reference ID/Investigator# 81938
Brentford, , United Kingdom
Site Reference ID/Investigator# 81940
Edinburgh, , United Kingdom
Site Reference ID/Investigator# 81939
London, , United Kingdom
Site Reference ID/Investigator# 92813
London, , United Kingdom
Site Reference ID/Investigator# 81937
Newcastle upon Tyne, , United Kingdom
Site Reference ID/Investigator# 81943
Oxford, , United Kingdom
Site Reference ID/Investigator# 82238
Preston, , United Kingdom
Countries
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References
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Haig G, Wang D, Othman AA, Zhao J. The alpha7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study. Neuropsychopharmacology. 2016 Nov;41(12):2893-2902. doi: 10.1038/npp.2016.101. Epub 2016 Jun 20.
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.
Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, Hanina A. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia. JMIR Mhealth Uhealth. 2017 Feb 21;5(2):e18. doi: 10.2196/mhealth.7030.
Other Identifiers
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2012-000418-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M10-855
Identifier Type: -
Identifier Source: org_study_id
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