Bipolar Disorder
Conditions
Keywords
Bipolar type I Disorder
Brief summary
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
Interventions
DRUGaripiprazole
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks | — |
Countries
United States
Outcome results
None listed