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

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: aripiprazole
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-402
  • IND #: 42,776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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