A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
NCT ID: NCT00888693
Last Updated: 2017-11-21
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
81 participants
INTERVENTIONAL
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288
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Placebo
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2
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288
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Placebo
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3
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288
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Placebo
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4
ABT288 vs placebo administered orally once daily for 14 days
ABT-288
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Placebo
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5
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288
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Placebo
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6
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288
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Placebo
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7
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288
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Placebo
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8
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288
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Placebo
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9
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288
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Placebo
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Interventions
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ABT-288
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Placebo
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Eligibility Criteria
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Inclusion Criteria
* Current DSM-IV-TR diagnosis of schizophrenia;
* Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
* Meets study-specific PANSS criteria;
* Willing and able to cooperate with cognitive testing
* 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 of schizoaffective disorder;
* Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
* Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
* Current clozapine treatment; suicidal ideation or behavior;
* BMI of 39 or greater; current homicidal or violent ideation;
* Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
* Positive hepatitis or HIV test result;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
* Visual, hearing or communication disability
18 Years
60 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Abbott
Countries
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References
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Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.
Other Identifiers
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M10-752
Identifier Type: -
Identifier Source: org_study_id