NCT00332787

Brief Summary

This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2000

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

First QC Date

June 1, 2006

Last Update Submit

January 7, 2014

Conditions

Depression

Keywords

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • Measured throughout the study: Relapse

  • Time to relapse

Secondary Outcomes (2)

  • Measured at Weeks 12 and 36: Functioning

  • Baseline characteristics

Interventions

FluoxetineDRUG

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Currently being treated on an outpatient basis
  • Currently attending school
  • Diagnosis of non-psychotic major depressive disorder (MDD)
  • Duration of illness is at least 4 weeks
  • In good general medical health
  • Normal intelligence

You may not qualify if:

  • Lifetime history of any psychotic disorder, including psychotic depression
  • Diagnosis of bipolar I or II disorder
  • History of alcohol or substance abuse or dependence within 6 months of study entry
  • Lifetime history of anorexia nervosa or bulimia
  • Pregnant or breastfeeding
  • Does not agree to use an effective form of contraception (i.e., IUD, birth control pills, or barrier devices)
  • Any chronic medical illness requiring regular medication
  • Currently taking medication with psychotropic effects (i.e., anticonvulsants, steroids, etc.), other than stable stimulant treatment
  • A first degree relative has bipolar I disorder
  • Previous adequate treatment with fluoxetine was ineffective (defined as at least 20 mg/day for 4 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center at Dallas, Outpatient Psychiatry Clinic

Dallas, Texas, 75235, United States

Location

Related Publications (4)

  • Kennard BD, Mayes TL, Chahal Z, Nakonezny PA, Moorehead A, Emslie GJ. Predictors and Moderators of Relapse in Children and Adolescents With Major Depressive Disorder. J Clin Psychiatry. 2018 Mar/Apr;79(2):15m10330. doi: 10.4088/JCP.15m10330.

    PMID: 29474007DERIVED

  • Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.

    PMID: 20973714DERIVED

  • Tao R, Emslie G, Mayes T, Nakonezny P, Kennard B, Hughes C. Early prediction of acute antidepressant treatment response and remission in pediatric major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):71-8. doi: 10.1097/CHI.0b013e318190043e.

    PMID: 19057412DERIVED

  • Kennard BD, Hughes JL, Stewart SM, Mayes T, Nightingale-Teresi J, Tao R, Carmody T, Emslie GJ. Maternal depressive symptoms in pediatric major depressive disorder: relationship to acute treatment outcome. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):694-699. doi: 10.1097/CHI.0b013e31816bfff5.

    PMID: 18434919DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Graham J. Emslie, MD

    UT Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

June 1, 2000

Study Completion

October 1, 2005

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

US(1)