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A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers

NCT01655680•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

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)

Locations (61)

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

Key Dates

Start Date

May 1, 2012

Primary Completion Date

April 1, 2014

Completion Date

July 1, 2014

Last Updated

July 7, 2021

Enrollment

432

ACTUAL participants

Conditions

Schizophrenia

Interventions

ABT-126

DRUG

ABT-126

DRUG

ABT-126

DRUG

Placebo

DRUG

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NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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