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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

aripiprazole

Intervention Type DRUG

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

Interventions

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aripiprazole

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

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes