Journal of the American Academy of Child & Adolescent Psychiatry
ArticlesEfficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial
Section snippets
Study Design
This was an 8-week, multicenter, double-blind, randomized, parallel-design comparison of paroxetine with placebo and imipramine with placebo in adolescents with major depression. The trial was conducted at 10 centers in the United States and 2 in Canada. Four hundred twenty-five subjects were screened for eligibility, and 275 subjects were randomly assigned to experimental treatment. The trial was conducted in accordance with good clinical practices and the Helsinki Declaration. All subjects
RESULTS
Treatment groups were similar with regard to demographic characteristics and psychiatric profile (Table 1). Most subjects had a first-degree relative with major depression and were experiencing their first episode of major depression. The mean duration of the current depressive episode was more than 1 year, with a mean baseline HAM-D total score between 18 and 19. Features of melancholic or endogenous depression were exhibited by 35% to 40% of patients, and 20% had features of atypical
DISCUSSION
This is the first study to compare efficacy of an SSRI and a tricyclic antidepressant with placebo in the treatment of major depression in adolescents. Paroxetine was significantly more effective than placebo with regard to achievement of both HAM-D total score ≤8, CGI score of 1 (very much improved) or 2 (much improved), and improvements in the depressed mood items of the HAM-D and the K-SADS-L. Paroxetine did not separate statistically from placebo for K-SADS-L depression subscore, mean CGI
REFERENCES (55)
- et al.
Multicenter open-label sertraline study in adolescent outpatients with major depression
J Am Acad Child Adolesc Psychiatry
(1999) - et al.
Fluvoxamine open-label treatment of adolescent inpatients with obsessive-compulsive disorder or depression
J Am Acad Child Adolesc Psychiatry
(1994) - et al.
Randomized, controlled trial of amitriptyline versus placebo for adolescents with “treatment-resistant” major depression
J Am Acad Child Adolesc Psychiatry
(1998) - et al.
Pharmacokinetically designed double-blind placebo-controlled study of nortriptyline in 6-to 12-year-olds with major depressive disorder
J Am Acad Child Adolesc Psychiatry
(1992) - et al.
Amitriptyline in children with major depressive disorder: a double-blind crossover pilot study
J Am Acad Child Psychiatry
(1984) - et al.
Suicidal behaviors and childhood-onset depressive disorders: a longitudinal investigation
J Am Acad Child Adolesc Psychiatry
(1993) - et al.
Prediction of response to fluoxetine and placebo in children and adolescents with major depression: a hypothesis generating study
J Affect Disord
(1999) - et al.
Clinical effects of amitriptyline in adolescent depression: a pilot study
J Am Acad Child Psychiatry
(1981) - et al.
Response to desipramine treatment in adolescent depression: a fixed-dose, placebo-controlled trial
J Am Acad Child Adolesc Psychiatry
(1994) - et al.
A randomized, controlled trial of amitriptyline in the acute treatment of a major depression
J Am Acad Child Adolesc Psychiatry
(1996)
Predictors of therapeutic benefit from amitriptyline in mild depression: a general practice placebo-controlled trial
J Affect Disord
Unipolar depression in adolescents: clinical outcome in adulthood
J Am Acad Child Adolesc Psychiatry
Paroxetine in children with major depressive disorder: an open trial
J Am Acad Child Adolesc Psychiatry
Child and adolescent mood disorders: experience with serotonin-based therapies
Biol Psychiatry
Use of placebo control groups in evaluating efficacy of treatment of unipolar major depression
Biol Psychiatry
Adolescent depression: a placebo-controlled fluoxetine treatment study and follow-up
Prog Neuropsychopharmacol Biol Psychiatry
Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
The Sickness Impact Profile: development and final revision of a health status measure
Med Care
Placebo as a treatment for depression
Neuropsychopharmacology
The safety and efficacy of paroxetine compared with placebo in a double-blind trial of depressed outpatients
J Clin Psychiatry
A comparison of fluoxetine, imipramine, and placebo in patients with major depressive disorder
J Clin Psychiatry
Paroxetine in major depression: a double-blind trial with imipramine and placebo
J Clin Psychiatry
Treatment of childhood and adolescent disorders
A comparison of paroxetine, imipramine, and placebo in depressed outpatients
Br J Psychiatry
The epidemiology of suicide in adolescents
Pediatr Ann
A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression
Arch Gen Psychiatry
Cited by (562)
Special Populations: Treatment-Resistant Depression in Children and Adolescents
2023, Psychiatric Clinics of North AmericaAntidepressants in children and adolescents with major depressive disorder and the influence of placebo response: A meta-analysis
2022, Journal of Affective DisordersTreatment-resistant depression in children and adolescents
2022, Managing Treatment-Resistant Depression: Road to Novel Therapeutics
This study was supported by a grant from GlaxoSmithKline, Collegeville, PA. The authors acknowledge the contributions of the following individuals: Jill M. Abbott, Ellen Basian, Ph.D., Carolyn Boulos, M.D., Elyse Dubo, M.D., Mary A. Fristad, Ph.D., Joan Hebeler, M.D., Kevin Kelly, Ph.D., Sharon Reiter, M.D., and Ronald A. Weller, M.D. Editorial assistance was provided by Sally K. Laden, M.S.