Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
2 other identifiers
interventional
20
1 country
4
Brief Summary
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2006
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedNovember 8, 2013
June 1, 2008
7 months
May 1, 2006
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Austin, Texas, United States
Local Institution
Bellaire, Texas, United States
Local Institution
Desota, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
July 1, 2006
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
November 8, 2013
Record last verified: 2008-06