Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: aripiprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc. Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug
interaction with lamotrigine.
Clinical Details
Official title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)
Secondary outcome: Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Local Institution, Philadelphia, Pennsylvania, United States
Local Institution, Austin, Texas, United States
Local Institution, Bellaire, Texas, United States
Local Institution, Desota, Texas, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: July 2006
Last updated: November 7, 2013
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