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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321516
• Other study ID #: CN138-402
• Secondary ID: IND #: 42,776
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2006
• Last updated: November 7, 2013
• Start date: July 2006
• Est. completion date: February 2007

Study information

• Verified date: June 2008
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Local Institution	Austin	Texas
United States	Local Institution	Bellaire	Texas
United States	Local Institution	Desota	Texas
United States	Local Institution	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm