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Olanzapine Compared to Quetiapine in Adolescents with a First Psychotic

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Olanzapine Compared to Quetiapine in Adolescents with a First Psychotic Olanzapine compared to quetiapine in adolescents with a first psychotic episode Celso Arango, Olalla Robles, Mara Parellada, David Fraguas, Ana Ruiz-Sancho, Oscar Medina, Arantzazu Zabala, Igor Bombín, Dolores Moreno To cite this version: Celso Arango, Olalla Robles, Mara Parellada, David Fraguas, Ana Ruiz-Sancho, et al.. Olanzapine compared to quetiapine in adolescents with a first psychotic episode. European Child and Adolescent Psychiatry, Springer Verlag (Germany), 2009, 18 (7), pp.418-428. 10.1007/s00787-009-0749-5. hal- 00478102 HAL Id: hal-00478102 https://hal.archives-ouvertes.fr/hal-00478102 Submitted on 30 Apr 2010 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Eur Child Adolesc Psychiatry (2009) 18:418–428 DOI 10.1007/s00787-009-0749-5 ORIGINAL CONTRIBUTION Celso Arango, MD, PhD Olanzapine compared to quetiapine in Olalla Robles, PhD Mara Parellada, MD, PhD adolescents with a first psychotic episode David Fraguas,MD Ana Ruiz-Sancho,MD Oscar Medina,MD Arantzazu Zabala, PhD Igor Bombı´n, PhD Dolores Moreno, MD, PhD j Abstract Objective To com- greater improvement for olanza- Received: 29 March 2008 Accepted: 9 December 2008 pare the efficacy, safety, and pine. Patients on olanzapine Published online: 5 February 2009 tolerability of olanzapine and gained 15.5 kg and patients on quetiapine in adolescents with first quetiapine gained 5.5 kg. Clinical Trials Registry: episode psychosis. Method Fifty Conclusion Olanzapine and Trial Registry name: Estudio piloto adolescents (age 16 ± 1.25) with a quetiapine reduced psychotic comparativo de quetiapina frente a first episode of psychosis were symptoms in this adolescent sam- olanzapina en pacientes con primeros brotes psico´ticos de inicio en la infancia randomized to quetiapine or ple. Patients on olanzapine gained y la adolescencia. olanzapine in a 6-month open significantly more weight. Side URL: http://www.agemed.es/ label study. Efficacy and side effect effects with both drugs seemed to Registration identification number: scales, as well as vital signs and be more prevalent than those 02-0300, SPGM-001. laboratory data were recorded at reported in adult studies. C. Arango, MD, PhD (&) Æ O. Robles, PhD baseline, 7, 15, 30, 90, and M. Parellada, MD, PhD 180 days (end of study). Results j Key words olanzapine – A. Ruiz-Sancho, MD Æ O. Medina, MD Out of the total sample included in quetiapine – safety – A. Zabala, PhD Æ D. Moreno, MD, PhD the study, 32 patients completed tolerability – adolescent – Psychiatry Department, Adolescent Unit Hospital General Universitario Gregorio the trial (quetiapine n = 16, olan- first episode psychosis Maran˜o´n zapine n = 16). Patients in both Centro de Investigacio´n Biome´dica treatment groups had a significant en Red de Salud Mental, CIBERSAM reduction in all clinical scales with C/Ibiza 43, 28009 Madrid, Spain Tel.: +34-91/5868133 the exception of the negative scale Fax: +34-91/4265108 of the Positive and Negative E-Mail: [email protected] Symptom Scale (PANSS) for olan- D. Fraguas, MD zapine and the general psychopa- Department of Psychiatry thology scale of the PANSS for Hospital Infanta Sofia quetiapine. The only difference San Sebastian de los Reyes between treatment arms on the Madrid, Spain clinical scales was observed on the I. Bombı´n, PhD patients’ strength and difficulties Neurological Rehabilitation Center questionnaire (SDQ) scale, with Oviedo, Spain Introduction efficacy or safety evidence from randomized con- trolled trials to support these prescribing trends in children and adolescents with psychotic symptoms There has been a drastic increase in the prescription [5]. In fact, there have been more studies with SGA for of antipsychotics in children and adolescents in the treatment of disruptive behaviors and develop- ECAP 749 recent years [32]. Nevertheless, there is very limited mental disorders than in patients with psychotic C. Arango et al. 419 Olanzapine and quetiapine in adolescence symptoms [8]. To our knowledge, only three double- according to DSM-IV criteria) were invited to participate blind studies have compared the efficacy of different in the study. All patients had a first episode of psychosis antipsychotics. Moreover, two of these studies were before the age of 18, lasting less than 1 year after onset of performed with a very low prevalence entity: the first positive symptom (mean duration of delusions treatment resistant patients with childhood-onset 0.3 ± 0.3 years; hallucinations 0.4 ± 0.5 years). Ado- schizophrenia [21, 37]. Kumra et al. [21] found that lescents were 12–18 years of age. clozapine was superior to haloperidol in the treatment Diagnostic information was collected at baseline by of 21 treatment resistant patients with prepubertal- means of the Kiddie-SADS-Present and Lifetime onset schizophrenia. In a more recent study, cloza- Version (K-SADS-PL). A clinical psychiatrist with pine was significantly superior to olanzapine only for formal training in the K-SADS-PL interviewed par- the treatment of negative symptoms [37]. In the only ticipants and administered diagnostic, psychiatric, other double-blind randomized study, Sikich et al. safety, and tolerability scales over the six research [38] studied 50 patients with psychotic symptoms, visits (see ‘‘Outcome measures’’ for scales and fre- with a mean length of illness of 2.4 years. Haloperidol, quency). The Internal Review Board (IRB) approved olanzapine, and risperidone showed similar efficacy all procedures, including recruitment and consent. in symptom reduction. In this study, weight gain and Written informed consent was obtained from partic- extrapyramidal effects appeared more prevalent and ipants and their parents or legal guardians prior to severe than reported in adults. Most studies are short enrollment in the study. term, usually lasting 6–8 weeks [37, 38]. We are not We excluded subjects if the psychotic symptoms aware of any previous randomized controlled trial appeared to result from acute intoxication or with- with two SGAs in first episode psychosis in adoles- drawal (if psychotic symptoms did not persist after cence. 14 days of a negative urine drug screening), if they This study was designed to provide prospective, met DSM-IV criteria for any substance abuse, mental randomized information at 6 months about the effi- retardation, or pervasive developmental disorder, cacy and safety of two-second generation antipsy- suffered from any organic central nervous system chotics widely prescribed in pediatric populations. disorder, had a history of traumatic brain injury with Based on previous studies in adult first episode psy- loss of consciousness, were pregnant or breast-feed- chosis and studies on tolerability in pediatric popu- ing, or were taking olanzapine or quetiapine before lations, we hypothesized that there would not be a enrolment. Use of other antipsychotic drugs other difference between quetiapine and olanzapine in than olanzapine or quetiapine before enrolment was terms of symptom reduction, and that side effects allowed. would be very prevalent in this population and dif- Patients were diagnosed again at 6 months by the ferent for the two antipsychotics. patient’s attending psychiatrist, according to DSM-IV criteria. The final sample included 17 patients with schizophrenia, 13 patients with bipolar disorder, and Methods 20 patients with ‘‘other’’ psychotic disorders. Specific diagnoses at 6 months for patients included in the j Study design two treatment arms are provided in Table 1. Figure 1 provides a detailed explanation of the flow of partic- This is a 6-month, comparative, randomized (que- ipants throughout the trial. tiapine vs. olanzapine), open label, parallel group study in adolescent patients with first episode psy- j Randomization chosis. In this article, we report on clinical efficacy, tolerability, and safety of antipsychotic drug treat- Adolescents were randomized to one of two treatment ment. However, the primary outcome for this trial was groups (quetiapine or olanzapine). Stratified random cognitive efficacy. Results for cognitive outcome are sampling was conducted according to two participant reported elsewhere (Robles et al., submitted). There- characteristics: age and gender. fore, here we focus on the clinical secondary variables. j Medication j Subjects Four patients randomized to quetiapine and eight Fifty patients consecutively admitted to the Adolescent patients randomized to olanzapine had previously Unit of Hospital General Universitario ‘‘Gregorio Mar- received antipsychotics (16.7% of the quetiapine an˜o´n’’ (Madrid, Spain) with a diagnosis of psychosis group and 30.8% of the olanzapine group). All pa- (i.e., schizophrenia or any other psychotic disorder tients were prescribed risperidone 2–6 mg (flexible 420 European Child & Adolescent Psychiatry (2009) Vol. 18, No. 7 Ó Steinkopff Verlag 2009 Table 1 Socio-demographic and clinical characteristics Variables Quetiapine Olanzapine Analysis n Mean SD n Mean SD Statistic dfd P Age (years)a 24 16.3 1.1 26 15.7 1.4 U – 0.132 Parental years of educationa 21 10.6 3.5 15 9.4
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