Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents

• ClinicalTrials.gov Identifier: NCT00332787
• Recruitment Status: Completed
• First Posted: June 2, 2006
• Last Update Posted: January 8, 2014
• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by: University of Texas Southwestern Medical Center

Study Description

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

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):

Kennard BD, Mayes TL, Chahal Z, Nakonezny PA, Moorehead A, Emslie GJ. Predictors and Moderators of Relapse in Children and Adolescents With Major Depressive Disorder. J Clin Psychiatry. 2018 Mar/Apr;79(2). pii: 15m10330. doi: 10.4088/JCP.15m10330.

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):694-699. doi: 10.1097/CHI.0b013e31816bfff5.

• 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
• 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:

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