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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

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Fluoxetine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Childhood Depression: Remission and Relapse
Study Start Date : June 2000
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine




Primary Outcome Measures :
  1. Measured throughout the study: Relapse
  2. Time to relapse

Secondary Outcome Measures :
  1. Measured at Weeks 12 and 36: Functioning
  2. Baseline characteristics


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332787


Locations
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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
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Graham J. Emslie, MD UT Southwestern Medical Center at Dallas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00332787    
Other Study ID Numbers: R01MH039188 ( U.S. NIH Grant/Contract )
R01MH039188 ( U.S. NIH Grant/Contract )
DSIR CT-M
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014
Keywords provided by University of Texas Southwestern Medical Center:
Major Depressive Disorder
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors