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

Tracking Information

First Received Date ^ICMJE

May 1, 2006

Last Updated Date

June 27, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00321516 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: aripiprazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00321516

Responsible Party

Study ID Numbers ^ICMJE

CN138-402, IND #: 42,776

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP