Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00849901 · ClinicalTrials.gov registry record · Phase 3

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
337
Enrollment target

NCT00849901: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00849901 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 337 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00849901, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
337 participants
Enrollment target

Study Summary

The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

Primary Outcome

CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatme

Interventions

  • DRUG Placebo
  • DRUG duloxetine
  • DRUG fluoxetine

Trial Details

FieldValue
Enrollment Target 337 participants
Start Date 2009-03
Est. Completion 2011-10
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00849901 record still lists

NCT00849901 is an interventional study that assigns participants to a tested intervention. The registered 337 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).

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

NCT00849901 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00849901 about?

NCT00849901 is a clinical study titled "A Study in the Treatment of Children and Adolescents With Major Depressive Disorder". The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

What is the current status of trial NCT00849901?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 337 participants. The study started on 2009-03. Estimated completion is 2011-10.

What interventions are being tested in trial NCT00849901?

The interventions under investigation include: Placebo (DRUG), duloxetine (DRUG), fluoxetine (DRUG).

Who is sponsoring clinical trial NCT00849901?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00849901's enrollment target sits among peer trials

337 1059th of 2000 higher than 941 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03253263 · 338 participants · Phase 2

    A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

  • NCT05658731 · 338 participants · NA

    Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients

  • NCT06022939 · 338 participants · Phase 3

    Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis

  • NCT03947385 · 336 participants · Phase 1

    Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00849901, the US trial registry maintained by the National Library of Medicine. NCT00849901 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.