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NCT00382291 · ClinicalTrials.gov registry record · Phase 4

Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder

A Phase 4 study, sponsored by University of Florida.

Completed
Registry status
Phase 4
Development phase
56
Enrollment target

NCT00382291: Completed Phase 4 study, sponsored by University of Florida.

NCT00382291 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00382291, a Phase 4 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 4
Development phase
56 participants
Enrollment target

Study Summary

This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.

Primary Outcome

The CGI-SA was adapted from the Clinical Global Impressions - Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA ob

Interventions

  • DRUG Placebo
  • DRUG Regular Titration
  • DRUG Slow Titration

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2009-02
Est. Completion 2011-02
Phase Phase 4
University of Florida

1,106 total trials

What the finished NCT00382291 record still lists

NCT00382291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00382291 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00382291 about?

NCT00382291 is a clinical study titled "Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder". This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.

What is the current status of trial NCT00382291?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2009-02. Estimated completion is 2011-02.

What interventions are being tested in trial NCT00382291?

The interventions under investigation include: Placebo (DRUG), Regular Titration (DRUG), Slow Titration (DRUG).

Who is sponsoring clinical trial NCT00382291?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00382291's enrollment target sits among peer trials

56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00382291, the US trial registry maintained by the National Library of Medicine. NCT00382291 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.