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NCT00958568 · ClinicalTrials.gov registry record · Phase 3

A Study in Relapse Prevention of Treatment-Resistant Depression

A Phase 3 study of Treatment-Resistant Depression, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
892
Enrollment target
20
Study locations

NCT00958568 is a Phase 3 study of Treatment-Resistant Depression that has completed, run by Eli Lilly and Company. The registered enrollment target is 892 participants, above the 357-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (150% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT00958568, a Phase 3 study of Treatment-Resistant Depression, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
892 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time (up to 47 weeks) and to assess the quality of life during treatment.

Interventions

  • DRUG Fluoxetine
  • DRUG Olanzapine and Fluoxetine combination (OFC)

Study Locations (20)

California

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Pasadena
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Sherman Oaks
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wildomar

Missouri

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bridgeton
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Saint Charles
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St Louis

Georgia

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Atlanta
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Marietta

Illinois

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chicago
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Oak Brook

Maryland

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Baltimore
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Glen Burnie

Massachusetts

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Belmont
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Boston

Connecticut

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Cromwell

District of Columbia

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Washington D.C.

Trial Details

FieldValue
Enrollment Target 892 participants
Start Date 2009-08
Est. Completion 2012-03
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT00958568

The ClinicalTrials.gov registry entry for NCT00958568 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 892 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 357-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (150% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 2 interventions - of which Fluoxetine is the first listed.

NCT00958568 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Missouri, Georgia.

Frequently Asked Questions

What is clinical trial NCT00958568 about?

NCT00958568 is a clinical study titled "A Study in Relapse Prevention of Treatment-Resistant Depression". The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long ti...

What is the current status of trial NCT00958568?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 892 participants. The study started on 2009-08. Estimated completion is 2012-03.

What conditions does trial NCT00958568 study?

This clinical trial studies the following conditions: Treatment-Resistant Depression.

What interventions are being tested in trial NCT00958568?

The interventions under investigation include: Fluoxetine (DRUG), Olanzapine and Fluoxetine combination (OFC) (DRUG).

Who is sponsoring clinical trial NCT00958568?

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

Where is trial NCT00958568 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Georgia, Illinois. 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.