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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00321516
First received: May 1, 2006
Last updated: November 7, 2013
Last verified: June 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aripiprazole
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Other Name: Abilify

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Austin, Texas, United States
Local Institution
Bellaire, Texas, United States
Local Institution
Desota, Texas, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00321516     History of Changes
Other Study ID Numbers: CN138-402, IND #: 42,776
Study First Received: May 1, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar type I Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Aripiprazole
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 28, 2014