Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole; Lamotrigine

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