Completed
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
What is being tested
ABT-126
+ ABT-126
+ Placebo
Drug
Who is being recruted
Mental Disorders
+ Schizophrenia Spectrum and Other Psychotic Disorders
+ Schizophrenia
From 20 to 55 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: August 2012
Summary
Principal SponsorAbbVie (prior sponsor, Abbott)
Last updated: July 7, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
Principal SponsorAbbVie (prior sponsor, Abbott)
Last updated: July 7, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
157 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 20 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersSchizophrenia Spectrum and Other Psychotic DisordersSchizophrenia
Criteria
5 inclusion criteria required to participate
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.)
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
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
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5 exclusion criteria prevent from participating
Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator
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 positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period
Has any risk factors for Torsades de Pointes (TdP)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalABT-126 Low Dose
Group II
ExperimentalABT-126 High Dose
Group III
PlaceboPlacebo
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 20 locations
Site Reference ID/Investigator# 74436
Chino, United StatesOpen Site Reference ID/Investigator# 74436 in Google MapsSite Reference ID/Investigator# 72704
Garden Grove, United StatesSite Reference ID/Investigator# 72699
National City, United StatesSite Reference ID/Investigator# 73983
Oceanside, United StatesCompleted20 Study Centers