Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00332787
First received: June 1, 2006
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Depression
Drug: Fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Childhood Depression: Remission and Relapse

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Measured throughout the study: Relapse
  • Time to relapse

Secondary Outcome Measures:
  • Measured at Weeks 12 and 36: Functioning
  • Baseline characteristics

Estimated Enrollment: 200
Study Start Date: June 2000
Estimated Study Completion Date: October 2005
Detailed Description:

Depression is a serious medical illness that affects all ages and populations. However, it has only been within the last 10 years that sufficient attention has been devoted to researching treatments for depression in children and adolescents. Symptoms of depression in this age group vary, but some common signs include pretending to be sick, refusing to go to school, clinging to a parent, or worrying that a parent may die. Older children may sulk, get into trouble at school, act in a negative or grouchy way, or feel misunderstood. Recent studies on selective serotonin reuptake inhibitors (SSRIs), one class of antidepressant medications, have shown that SSRIs are effective in reducing depression symptoms. The optimal duration of treatment, however, has yet to be established. 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.

Participants in this study will first attend three study visits over a 2-week period to determine eligibility. All eligible individuals will be treated with fluoxetine for 12 weeks. Dosages will be determined by the study physician and will be based on clinical response to treatment. Study visits will occur weekly for the first 4 weeks and biweekly for the remaining 2 months. Depression symptoms, general changes, and adverse reactions will be assessed. Participants whose symptoms have improved will be eligible to enter the discontinuation phase of the study, which will entail random assignment to either fluoxetine or placebo for an additional 24 weeks. Study visits will occur biweekly for 3 months and monthly for the remaining 3 months. Depression symptoms and medication side effects will be assessed at these visits.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332787

Locations
United States, Texas
Children's Medical Center at Dallas, Outpatient Psychiatry Clinic
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Graham J. Emslie, MD UT Southwestern Medical Center at Dallas
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00332787     History of Changes
Other Study ID Numbers: R01 MH39188, R01MH039188, DSIR CT-M
Study First Received: June 1, 2006
Last Updated: January 7, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Texas Southwestern Medical Center:
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014