Fluoxetine versus placebo in preventing relapse of major depression in children and adolescents
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Objective The authors compared fluoxetine and placebo in continuation treatment to prevent relapse of major depressive disorder in children and adolescents. Method After a detailed evaluation, children and adolescents 7-18 years of age with major depressive disorder were treated openly with fluoxetine. Those who had an adequate response after 12 weeks, as indicated by a Clinical Global Impression improvement score of 1 or 2 and a decrease of at least 50% in Children's Depression Rating Scale-Revised score, were randomly assigned to receive fluoxetine or placebo for an additional 6 months. The primary outcome measures were relapse and time to relapse. Relapse was defined as either a score of 40 or higher on the Children's Depression Rating Scale with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. Additional analyses were conducted with relapse defined only as a score of 40 or higher on the Children's Depression Rating Scale. Results Of 168 participants enrolled in acute fluoxetine treatment, 102 were randomly assigned to continuation treatment with fluoxetine (N=50) or placebo (N=52). Of these, 21 participants (42.0%) in the fluoxetine group relapsed, compared with 36 (69.2%) in the placebo group, a significant difference. Similarly, under the stricter definition of relapse, fewer participants in the fluoxetine group relapsed (N=11; 22.0%) than in the placebo group (N=25; 48.1%). Time to relapse was significantly shorter i…
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Medication trials all involved SSRIs; three administered fluoxetine and one sertraline.
“Medication trials all involved SSRIs; three trials administered fluoxetine (Emslie 2004; Emslie 2008; Kennard 2008) and one involved sertraline (Cheung 2008).”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
Three trials (Cheung 2008; Emslie 2004; Emslie 2008) provided data suitable for at least one outcome in the meta-analysis.
“Three trials (Cheung 2008; Emslie 2004; Emslie 2008) provided data suitable for at least one outcome in the meta-analysis.”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
During relapse-prevention, three trials compared medication with placebo and one compared combination therapy with medication alone.
“During the relapse prevention phase, three trials compared medication with a placebo pill (Cheung 2008; Emslie 2004; Emslie 2008) and one trial compared a combination of psychotherapy and medication with medication alone (Kennard 2008).”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
During acute treatment, one trial openly treated all participants with sertraline and two others with fluoxetine.
“During the acute phase of treatment, one trial openly treated all participants with sertraline (Cheung 2008) and two others treated participants with fluoxetine (Emslie 2008; Kennard 2008).”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
Four trials contained continuation or maintenance phases specifically designed to prevent relapse-recurrence after initial response.
“Four trials contained continuation or maintenance phases (or both) specifically designed to prevent relapse-recurrence after initial response, and involved only those participants who had responded or remitted after an acute phase of treatment (Cheung 2008; Emslie 2004; Emslie 2008; Kennard 2008).”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
Three trials contained children and adolescents aged 7-18; one contained adolescents aged 13-19.
“Three trials contained both children and adolescents between the ages of 7 and 18 years (Emslie 2004; Emslie 2008; Kennard 2008) and one contained adolescents between 13 and 19 years (Cheung 2008).”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
In two trials, acute phase treatment lasted 12 weeks before maintenance and re-randomisation.
“In two trials, acute phase treatment lasted 12 weeks (Emslie 2008; Kennard 2008), at which point participants entered a maintenance phase and were re-randomised, potentially to a new treatment arm.”
From Interventions for preventing relapse and recurrence of a depressive disorder in children and adolescents (2012) · cites this paper as Emslie 2008
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- Authors
- Emslie, G. J., Kennard, B. D., Mayes, T. L., Nightingale-Teresi, J., Carmody, T., Hughes, C. W., Rush, A. J., Tao, R., & Rintelmann, J. W.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- Venue
- American Journal of Psychiatry
- Published
- 2008-04
- Volume
- 165
- Issue
- 4
- Pages
- 459-467
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- PMC
- PMC2824429
- OpenAlex
- W2118838026
- Cited by
- 188
- References
- 13
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 6 · 2023: 6 · 2022: 9 · 2021: 3 · 2020: 5 · 2019: 9 · 2018: 10 · 2017: 5 · 2016: 16 · 2015: 9 · 2014: 14 · 2013: 12 · 2012: 11
- FWCI
- 14.08
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (R01MH039188)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- fluoxetine, major depressive disorder, childhood depression, adolescent depression, relapse prevention, continuation treatment, placebo comparison, time to relapse
- MeSH terms
- Adolescent, Age Factors, Child, Major Depressive Disorder, Double-Blind Method, Drug Administration Schedule, Female, Fluoxetine, Follow-Up Studies, Humans, Male, Placebos, Severity of Illness Index, Treatment Outcome, Selective Serotonin Reuptake Inhibitors, Secondary Prevention
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