- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678755
A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
July 2, 2021 updated by: AbbVie (prior sponsor, Abbott)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers
This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
-
Chino, California, United States, 91710
- Site Reference ID/Investigator# 74436
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Garden Grove, California, United States, 92845
- Site Reference ID/Investigator# 72704
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National City, California, United States, 91950
- Site Reference ID/Investigator# 72699
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Oceanside, California, United States, 92056
- Site Reference ID/Investigator# 73983
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Orange, California, United States, 92868
- Site Reference ID/Investigator# 73236
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San Diego, California, United States, 92102
- Site Reference ID/Investigator# 86974
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Torrance, California, United States, 90502
- Site Reference ID/Investigator# 72701
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Florida
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Bradenton, Florida, United States, 34201
- Site Reference ID/Investigator# 75314
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Maitland, Florida, United States, 32751
- Site Reference ID/Investigator# 75146
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Georgia
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Atlanta, Georgia, United States, 30308
- Site Reference ID/Investigator# 75654
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Illinois
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Chicago, Illinois, United States, 60640
- Site Reference ID/Investigator# 72703
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Hoffman Estates, Illinois, United States, 60169
- Site Reference ID/Investigator# 76534
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Louisiana
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Lake Charles, Louisiana, United States, 70629
- Site Reference ID/Investigator# 73984
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Missouri
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Saint Louis, Missouri, United States, 63109
- Site Reference ID/Investigator# 73981
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New Jersey
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Marlton, New Jersey, United States, 08053
- Site Reference ID/Investigator# 89553
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New York
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Cedarhurst, New York, United States, 11516
- Site Reference ID/Investigator# 72700
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New York, New York, United States, 10065
- Site Reference ID/Investigator# 73982
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
- Site Reference ID/Investigator# 113035
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Texas
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DeSoto, Texas, United States, 75115
- Site Reference ID/Investigator# 72702
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Houston, Texas, United States, 77008
- Site Reference ID/Investigator# 75147
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo
|
EXPERIMENTAL: ABT-126 Low Dose
|
ABT-126 Low Dose
ABT-126 High Dose
|
EXPERIMENTAL: ABT-126 High Dose
|
ABT-126 Low Dose
ABT-126 High Dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
Time Frame: Change from baseline to week 12
|
Rater based interview
|
Change from baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Time Frame: Measurements from screening period up through week 12
|
Rater based interview
|
Measurements from screening period up through week 12
|
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
Time Frame: Measurements from screening period up through week 12
|
Rater based interview
|
Measurements from screening period up through week 12
|
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Time Frame: Measurements from screening period up through week 12
|
Rater based interview
|
Measurements from screening period up through week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
March 1, 2014
Study Completion (ACTUAL)
March 1, 2014
Study Registration Dates
First Submitted
August 31, 2012
First Submitted That Met QC Criteria
September 4, 2012
First Posted (ESTIMATE)
September 5, 2012
Study Record Updates
Last Update Posted (ACTUAL)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-608
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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