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NCT00321516 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Bipolar Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
4
Study locations

NCT00321516 is a Phase 1 study of Bipolar Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 20 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT00321516, a Phase 1 study of Bipolar Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
4
Study locations

Study Summary

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

Conditions Studied

Interventions

  • DRUG aripiprazole

Study Locations (4)

Texas

  • Local Institution - Austin
  • Local Institution - Bellaire
  • Local Institution - Desota

Pennsylvania

  • Local Institution - Philadelphia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2006-07
Est. Completion 2007-02
Phase Phase 1

What the Registry Record Tells You About NCT00321516

The ClinicalTrials.gov registry entry for NCT00321516 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (94% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which aripiprazole is the first listed.

NCT00321516 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Texas, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00321516 about?

NCT00321516 is a clinical study titled "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.

What is the current status of trial NCT00321516?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-07. Estimated completion is 2007-02.

What conditions does trial NCT00321516 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT00321516?

The interventions under investigation include: aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00321516?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00321516 being conducted?

This trial has 4 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.