Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
NCT ID: NCT00321516
Last Updated: 2013-11-08
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
20 participants
INTERVENTIONAL
2006-07-31
2007-02-28
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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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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1
aripiprazole
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Interventions
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aripiprazole
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry
* Men and women, ages 18 to 65
Exclusion Criteria
* Patients with any significant acute or chronic medical illness, other than bipolar I disorder
* Subjects with active psychotic symptoms
* History of head trauma within the past 2 years
* History of akathisia requiring treatment
* History of tardive dyskinesia or abnormal involuntary movements
* Subjects with a predisposition to orthostatic hypotension
* Positive urine screen for drugs of abuse
* Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start
18 Years
65 Years
ALL
Yes
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Austin, Texas, United States
Local Institution
Bellaire, Texas, United States
Local Institution
Desota, Texas, United States
Countries
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Other Identifiers
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IND #: 42,776
Identifier Type: -
Identifier Source: secondary_id
CN138-402
Identifier Type: -
Identifier Source: org_study_id