Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
- Registration Number
- NCT00321516
- Brief Summary
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 aripiprazole -
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
Trial Locations
- Locations (1)
Local Institution
🇺🇸Desota, Texas, United States