Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents - Full Text View

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:

Drug Information available for: Fluoxetine

U.S. FDA Resources

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 (Child, Adult)
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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Graham J. Emslie, MD	UT Southwestern Medical Center at Dallas

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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):694-9. doi: 10.1097/CHI.0b013e31816bfff5.


ClinicalTrials.gov Identifier:	NCT00332787 History of Changes
Other Study ID Numbers:	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 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

ClinicalTrials.gov processed this record on September 27, 2016