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NCT00176202 · ClinicalTrials.gov registry record · Phase 3

Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar

A Phase 3 study, sponsored by University of Illinois at Chicago.

Completed
Registry status
Phase 3
Development phase
65
Enrollment target

NCT00176202: Completed Phase 3 study, sponsored by University of Illinois at Chicago.

NCT00176202 is a Phase 3 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00176202, a Phase 3 study, has completed, sponsored by University of Illinois at Chicago.

COMPLETED
Registry status
Phase 3
Development phase
65 participants
Enrollment target

Study Summary

The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

Primary Outcome

This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior

Interventions

  • DRUG Divalproex Sodium
  • DRUG risperidone

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2003-04
Est. Completion 2008-01
Phase Phase 3
University of Illinois at Chicago

430 total trials

What the finished NCT00176202 record still lists

NCT00176202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Divalproex Sodium is the first listed.

NCT00176202 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00176202 about?

NCT00176202 is a clinical study titled "Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar". The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

What is the current status of trial NCT00176202?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2003-04. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00176202?

The interventions under investigation include: Divalproex Sodium (DRUG), risperidone (DRUG).

Who is sponsoring clinical trial NCT00176202?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00176202's enrollment target sits among peer trials

65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00176202, the US trial registry maintained by the National Library of Medicine. NCT00176202 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.