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Eur Child Adolesc Psychiatry (2009)18:131–135 DOI 10.1007/s00787-007-0634-z A randomized controlled clinical trial of Citalopram versus Fluoxetine in childrenand adolescents with obsessive-compulsivedisorder (OCD) Accepted: 16 January 2007Published online: 3 February 2009 severity was measured by Yale–Brown Obsessive-Compulsive Iran University of Medical SciencesTehran, Iran reducing obsessive-compulsive symptom severity inchildren and adolescents , ], but there are no Accumulating clinical and epidemiological data indi- controlled trial to support the use of Citalopram in cate that OCD is more common than previously rec- children and adolescents with OCD. Citalopram is re- ognized in both children and adults; recent estimates of ported to be effective in early-onset Depression prevalence range from 0.5% to 3.0% [Children and The purpose of this study was to compare the adolescents evaluated in clinical settings often have efficacy and side effects profile of these two drugs symptoms of severity to warrant treatment , ], in children and adolescents with OCD. Assessment which may include behavioral therapy [] and/or included severity ratings of obsessive-compulsive ECAP medication particularly SSRIs ]. Controlled clinical symptoms, functional impairment, presence of com- 634 trials with Fluoxetine indicate that it is effective in European Child & Adolescent Psychiatry (2009) Vol. 18, No. 3Ó Steinkopff Verlag 2009 Once deemed eligible for the study, an overall clini-cian rating of obsessive-compulsive symptoms CGI-S From May 1999 through September 2002, 29 children and functional impairment Children’s Global Assess- and adolescents were evaluated in the child and ado- lescent psychiatry outpatient clinic at Roozbeh hospi-tal, Tehran. To be included in the study, subjects had to meet DSM-IV criteria for OCD made by an experiencedchild psychiatrist (JA or MS), be between the ages of The children’s Yale–Brown obsessive-compulsive 8 years and 17 years, have at least moderate symptoms Scale (CYBOCS) is a clinician-rated instrument for the of OCD as measured on the Clinical Global Impression Severity Scale (CGI-S), and have written informed severity in children with demonstrated reliability and parental consent and assent in children old enough to validity (18). Obsessions and compulsions are on 5 understand the purpose of the study.
separate scales yielding three summary scores; Children with date table organic brain disorder; Obsessive (0–20), Compulsions (0–20) and a Total those with a significant medical condition or those score (0–40). The CYBOCS was administrated by an currently receiving SSRI for OCD were excluded from experienced clinician (MS) repeated at weeks 3 and 6.
(CGI-I) compares current severity to baseline. Ascore 1 or 2 corresponds with Very Much Improved and Much Improved; 3 denotes minimal change and4 represents no change. Scores above 4 are used to After initial clinical evaluation, consenting subjects indicate deterioration such that 5 equals Minimally were randomly assigned to start with either Fluoxe- Worse and 6 or 7 correspond with Much Worse or tine 20 mg/day or Citalopram 20 mg/day. The double- Very Much Worse. The CGI-I rated by the same blind treatment period lasted for 6 weeks with out- clinician who administered the CYBOCS, was re- come and safety assessments done every 3 weeks.
peated at weeks 3 and 6. Side effects ratings: all Compliance was monitored by pill counts. A 3- positive Findings elicited during the interview were week supply of medication was provided at each visit, and parents were instructed to return all unusedmedication at each scheduled visit. No additionalpsychoactive medications were administered during the study. No subjects were receiving special educa-tional programs or behavioral treatments. Interviewer Student’s t-test was used to compare Fluoxetine and conducted a semi structural interview and adminis- Citalopram groups at baseline on all clinical symp- tered the symptom severity ratings, functional toms as well as demographic and medical variables.
impairment and side effects instruments (Table ).
Analysis of covariance (ANCOVA) was used to test for change on each clinical measure between baselineand 3-week scores within each treatment group and then between 3-week scores and 6-week scores withineach treatment group.
Baseline versus six weeks change scores for each In the screening visit, subjects received a thorough subject was then compared across treatment groups psychiatric, medical and neurological examination by for each clinical variable using student’s t-test. All t- an experienced child psychiatrist (JA or MS). This included a structured diagnostic interview, DICA ], to evaluate for exclusionary comorbid conditions.
During the study period, 29 children (17 boys and 12girls) who met criteria for OCD were evaluated and entered the study. None of them had received previ- ous treatment for OCD. There were 15 subjects in the Fluoxetine treatment group and 14 subjects in the Citalopram group. Twenty-four of the 29 subjects completed the 6 weeks trial. Four subjects dropped out after 3 weeks of treatment. The other patient was Table 2 Overall clinical response to fluoxetine treatment CGI score
Fig. 2 CY-BOCS changes during the first 6 weeks of treatment Fig. 1 CGI changes during the 6 weeks of treatment At sixth week of treatment, obsessive-compulsive excluded because of occurring hypomanic episode.
symptom severity for both groups decreased equally, Data from 24 to 29 subjects who began the study were as measured by CY-BOCS total scores. On the CY- BOCS, scores decreased for both obsessions and For all analyses we used the primary outcome compulsions (p < 0.01). CGI score didn’t change measures, the CY-BOCS total score and CGI-OCD significantly from baseline in both groups (p = NS).
(Figs. and There were no statistically significantdifferences between Fluoxetine and groups across symptom-severity ratings, demo-graphic characteristics or psychiatric comorbidities.
The most frequently reported side effects were: obsessive-compulsive symptom severity was moder- Headache 1 (3.4%), Tremor 2 (6.8%), Insomnia 1 ately high with an overall mean of 26.9± for the whole (3.4%), Hypomanic Episode 1 (3.4%) for fluoxetine.
group. The mean CGI of 51.5± showed that as a group, Headache 1 (3.4%), Hypomanic Episode 1 (3.4%) for these patients were substantially impaired. DICA indicated a high degree of comorbidities. The mean The frequency of comorbid current psychiatric diag- CGI score indicated a lower degree of functional noses, made by consensus of the same clinicians using impairment in comparison with the clinically ob- DICA , ], was as it follows: Tic disorder: 7 served obsessive-compulsive symptoms. This may (21.28%), Oppositional Defiant Disorder: 7 (21.28%), reflect perfectionistic traits in patients with OCD that Mood disorder: 6 (20.4%), Phobia: 4 (13.6%), Atten- prevents them from severe functional decline.
Generalized Anxiety Disorder: 3 (10.2%), Trichotil- lomania: 1 (3.4%).
It should be noted that in 66% of cases, OCD was After 3 weeks of treatment, obsessive-compulsive symptom severity for both groups decreased equally,as measured by CY-BOCS total scores. On the CY-BOCS, scores decreased for both obsessions and CGI scores didn’t change significantly from base- The findings of this study suggest that Citalopram is as safe and effective as Fluoxetine for short-term European Child & Adolescent Psychiatry (2009) Vol. 18, No. 3Ó Steinkopff Verlag 2009 Table 3 Overall clinical response to citalopram treatment showed greater improvement, as assessed by CY-BOCS (p = 0.026).
Most of the observed side effects, such as insom- nia, headache, and tremor, were expected, on the basis of our earlier experience with Citalopram in open-label trials [, Citalopram had to be dis-continued in only one subject because of occurringhypomanic episode.
treatment of OCD in children and adolescents. In line with other studies, we also found that 73% of thepatients had comorbid disorder especially tic disor- OCD can create emotional distress and functional impairment. There is no controlled trial about pre- In 66% of cases, OCD was reported in the families scribing citalopram in children and adolescents.
as well. The medication side effects were not signifi- Investigation into the use of Citalopram is a necessity.
cant. Citalopram had to be discontinued in one sub- Citalopram has a shorter half-life than fluoxetine and ject who developed manic episode. Decreases in mean can be effective in some special cases It also has obsessive-compulsive symptom severity; averaged few side effects. As SSRIs have increasingly become 56.1% depending on the assessment instrument used, the first choice treatment of OCD in children and and were seen after six weeks of treatment. Four adolescents, it is very important to have efficacy and subjects dropped out of the study because of non- safety data on as many of them as possible. This would help us to handle the wide individual differ- We observed lower degree of functional impair- ences in drug metabolism. There might also be sub- ment while high degrees of obsessive-compulsive groups of OCD patients who respond differentially to symptoms were rated. It might be due to perfectionist various SSRIs. Therefore, further investigation into traits that prevent them from severe functional decline. This is in line with previous studies.
Taken together, these findings suggest that both drugs are equally effective and safe. However, largernumber of children with OCD will need to be studied The most important limitation of our study includes in order to definitively establish efficacy and safety of the small sample size. Also, our patients admitted at a tertiary referral center are more likely to present with The degree of symptomatic improvement during psychiatric comorbidities than patients who do not Citalopram treatment observed in this study is com- seek treatment. The other limitation is comparing two parable with those observed in trials of Fluoxetine in active treatments without considering placebo group.
children and adolescents (Table ). In a 20-week, Moreover, we have used only one OCD severity double blind, crossover trial of Fluoxetine and pla- measure before giving the medications.
cebo involving 14 subjects obsessive-compulsivesymptom severity decreased 44% across CGI-OCDduring Fluoxetine treatment. In a 13-week, double j Acknowledgment The authors thankfully acknowledge the help- blind, placebo-controlled study of Fluoxetine involv- ful and rewarding comments made by Dr. Larry Scahill, Yale child ing 103 subjects [], obsessive-compulsive symptom adolescence: an epidemiological study.
Whole blood serotonin and disruptivebehaviors in juvenile obsessive-com-pulsive disorder. J Am Acad ChildAdolesc Psychiatry 34(1):28–35 sive Scale: reliability and validity. J Am 11. Riddle MA, Scahill L, King RA, Hardin

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