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

This study has been completed.

First Received: May 1, 2006 Last Updated: June 27, 2008 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00321516

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder	Drug: aripiprazole	Phase I

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine Aripiprazole

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	July 2006
Study Completion Date:	February 2007

Arms	Assigned Interventions
1: Experimental	Drug: aripiprazole Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321516

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CN138-402, IND #: 42,776
Study First Received:	May 1, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00321516 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Bipolar type I Disorder

Additional relevant MeSH terms:

Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Cardiovascular Agents
Antipsychotic Agents
Pharmacologic Actions

Membrane Transport Modulators
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Aripiprazole
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010