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Completed

NCT Number: NCT00321516

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

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

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.

Other names: Abilify

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 3, 2006
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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