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

Completed · Phase 1

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00321516

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

20

Starts

2006-07-01

Expected to finish

2007-02-01

Last updated by the study team

2013-11-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Local Institution — Philadelphia, Pennsylvania, United States
• Local Institution — Austin, Texas, United States
• Local Institution — Bellaire, Texas, United States
• Local Institution — Desota, Texas, United States

Full record on ClinicalTrials.gov

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