Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
NCT ID: NCT01043458
Last Updated: 2010-11-02
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
PHASE1
16 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
ABT-126 Low Dose
ABT-126
ABT-126 Low Dose \& ABT-126 High Dose
2
ABT-126 High Dose
ABT-126
ABT-126 Low Dose \& ABT-126 High Dose
3
Placebo for ABT-126
Placebo for ABT-126
Matching Placebo for Arms 1 \& 2
Interventions
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ABT-126
ABT-126 Low Dose \& ABT-126 High Dose
Placebo for ABT-126
Matching Placebo for Arms 1 \& 2
Eligibility Criteria
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Inclusion Criteria
* Current diagnosis of schizophrenia;
* Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
* Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
* Females are not pregnant, not breast-feeding;
* Females are post-menopausal or surgically sterile or practicing birth control;
* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
Exclusion Criteria
* Diagnosis with mental retardation;
* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Acute psychosis hospitalization within past 6 months;
* Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
* Current clozapine treatment;
* Suicidal ideation or behavior;
* BMI of 39 or greater;
* Relevant drug sensitivity or allergy;
* Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
18 Years
55 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Site Reference ID/Investigator# 25423
Glendale, California, United States
Site Reference ID/Investigator# 24322
San Antonio, Texas, United States
Countries
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Other Identifiers
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M11-108
Identifier Type: -
Identifier Source: org_study_id