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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Bipolar Disorder

Treatments: Drug: aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321516

CN138-402

IND #: 42,776

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 1 patient group

1

Experimental group

Treatment:

Drug: aripiprazole