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NCT00195767 · ClinicalTrials.gov registry record · Phase 3

Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

A Phase 3 study, sponsored by Abbott.

Completed
Registry status
Phase 3
Development phase
150
Enrollment target

NCT00195767 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 150 participants.

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The verdict

NCT00195767, a Phase 3 study, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 3
Development phase
150 participants
Enrollment target

Study Summary

To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.

Interventions

  • DRUG divalproex sodium

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2004-07
Phase Phase 3

Sponsor

Abbott

181 total trials

What the Registry Record Tells You About NCT00195767

The ClinicalTrials.gov registry entry for NCT00195767 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which divalproex sodium is the first listed.

NCT00195767 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00195767 about?

NCT00195767 is a clinical study titled "Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents". To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.

What is the current status of trial NCT00195767?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2004-07.

What interventions are being tested in trial NCT00195767?

The interventions under investigation include: divalproex sodium (DRUG).

Who is sponsoring clinical trial NCT00195767?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

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.