Status:
COMPLETED
Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
Eligibility Criteria
Inclusion
- Body mass index (BMI) of 18 to 40 kg/m2
- 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
- Women who are pregnant or breastfeeding
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00321516
Start Date
July 1 2006
End Date
February 1 2007
Last Update
November 8 2013
Active Locations (4)
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1
Local Institution
Philadelphia, Pennsylvania, United States
2
Local Institution
Austin, Texas, United States
3
Local Institution
Bellaire, Texas, United States
4
Local Institution
Desota, Texas, United States