PMID- 10933119 OWN - NLM STAT- MEDLINE DCOM- 20010109 LR - 20131121 IS - 1044-5463 (Print) IS - 1044-5463 (Linking) VI - 10 IP - 2 DP - 2000 Summer TI - Efficacy and safety findings from naturalistic fluoxetine drug treatment in adolescent and young adult patients. PG - 91-102 AB - This article reports on the efficacy and safety of the selective serotonin reuptake inhibitor, fluoxetine, in 213 patients (ages 11-23 years) treated by psychiatrists/neurologists (PN) or general practitioners/internists (GPI). Data were derived from naturalistic drug utilization observation (DUO) studies with fluoxetine (n = 18,759 patients). Data collection--at the start and the end of the observation period (< or =6 weeks)--included patient characteristics, diagnoses, medication, co-medication, efficacy, and adverse events (AEs). Nonparametric statistics and descriptive p values (two-tailed) were used. Analyses revealed various differences between PN (n = 56) and GPI (n = 157) samples as to patient and treatment characteristics (p < 0.001-0.08). Based on both Clinical Global Impression (CGI; all p < 0.001) and self-assessment (total n = 47; Zung SDS, all p < or = 0.003), both PN and GPI patients showed improvements in their symptomatology over time, including suicidality (all p < 0.001; there were no group differences). Overall AE rates were higher in PN patients (p < 0.01; 17.9% vs. 4.5%); the frequency and type of AEs in both subgroups were typical for fluoxetine and the total DUO samples. In fact, AE rates were lower compared to controlled trials. Findings suggest that PN patients were more severely ill at observation start and suffered a more complicated treatment course. However, clinical efficacy showed highly significant improvements in both subgroups; AE rates were low in both--although higher in PN patients. Thus, results support a positive benefit/risk ratio of fluoxetine use for this young patient population. FAU - Dittmann, R W AU - Dittmann RW AD - Psychosomatic Department, Children's Hospital, University of Hamburg, Germany. DITTMANN_RALF_W@Lilly.com FAU - Czekalla, J AU - Czekalla J FAU - Hundemer, H P AU - Hundemer HP FAU - Linden, M AU - Linden M LA - eng PT - Clinical Trial PT - Journal Article PL - United States TA - J Child Adolesc Psychopharmacol JT - Journal of child and adolescent psychopharmacology JID - 9105358 RN - 0 (Antidepressive Agents, Second-Generation) RN - 01K63SUP8D (Fluoxetine) SB - IM MH - Adolescent MH - Adult MH - Antidepressive Agents, Second-Generation/*adverse effects/*therapeutic use MH - Child MH - Comorbidity MH - Depressive Disorder/*drug therapy/psychology MH - Drug Interactions MH - Female MH - Fluoxetine/*adverse effects/*therapeutic use MH - Humans MH - Male MH - Psychiatric Status Rating Scales MH - Suicide/psychology EDAT- 2000/08/10 11:00 MHDA- 2001/02/28 10:01 CRDT- 2000/08/10 11:00 PHST- 2000/08/10 11:00 [pubmed] PHST- 2001/02/28 10:01 [medline] PHST- 2000/08/10 11:00 [entrez] AID - 10.1089/cap.2000.10.91 [doi] PST - ppublish SO - J Child Adolesc Psychopharmacol. 2000 Summer;10(2):91-102. doi: 10.1089/cap.2000.10.91.