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Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00332787
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : January 8, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE June 1, 2006
First Posted Date  ICMJE June 2, 2006
Last Update Posted Date January 8, 2014
Study Start Date  ICMJE June 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
  • Measured throughout the study: Relapse
  • Time to relapse
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
  • Measured at Weeks 12 and 36: Functioning
  • Baseline characteristics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents
Official Title  ICMJE Childhood Depression: Remission and Relapse
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Drug: Fluoxetine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 1, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332787
Other Study ID Numbers  ICMJE R01MH039188( U.S. NIH Grant/Contract )
R01MH039188 ( U.S. NIH Grant/Contract )
DSIR CT-M
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Graham J. Emslie, MD UT Southwestern Medical Center at Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP