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Trial record 95 of 218 for:    Lamotrigine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321516
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : November 8, 2013
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: aripiprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
Study Start Date : July 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: aripiprazole
Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Other Name: Abilify

Primary Outcome Measures :
  1. 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 :
  1. Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321516

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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.
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Layout table for additonal information Identifier: NCT00321516    
Other Study ID Numbers: CN138-402
IND #: 42,776
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: June 2008
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar type I Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Sodium Channel Blockers