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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00332787 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Childhood Depression: Remission and Relapse |
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2000 |
| Estimated Study Completion Date: | October 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Children's Medical Center at Dallas, Outpatient Psychiatry Clinic | |
| Dallas, Texas, United States, 75235 | |
| Principal Investigator: | Graham J. Emslie, MD | UT Southwestern Medical Center at Dallas |
More Information
| Study ID Numbers: | R01 MH39188, DSIR CT-M |
| Study First Received: | June 1, 2006 |
| Last Updated: | June 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00332787 History of Changes |
| Health Authority: | United States: Federal Government |
|
Major Depressive Disorder |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions |
Behavioral Symptoms Fluoxetine Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |