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

Tracking Information

• First Submitted Date: June 1, 2006
• First Posted Date: June 2, 2006
• Last Update Posted Date: January 8, 2014
• Study Start Date: June 2000
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: June 1, 2006)

• Measured throughout the study: Relapse
• Time to relapse

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 1, 2006)

• Measured at Weeks 12 and 36: Functioning
• Baseline characteristics

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Depression
• Intervention: Drug: Fluoxetine
• Study Arms: Not Provided

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 1, 2006): 200
• Original Enrollment: Same as current
• Study Completion Date: October 2005
• Primary Completion Date: Not Provided

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00332787
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

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

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: January 2014