IP-12-19!

P Poster Presentations

efficacy and CHESS for tolerance. ANOYA was used for comparison ofquantitative variables and X2 or Fisher exact test for qualitative variables:

- 87 patients completed the study in the sertraline group and 77 in theftuoxetine group with:

- 10 (8.5%) patients dropped out for side effect in the sertraline groupand 12 (10%) in the ftuoxetine group.

- At six month improvement over baseline was significant for depres­sion (Hamilton and HAD p < 0.001), anxiety (COYI p < 0.001), sleep(Leeds p < 0.001) and on most of the sub-scores, as well as on the totalscore of the SIP (quality of life) scale (p < 0.001).

The magnitude of change on depression anxiety, sleep and quality oflife was larger with sertraline than with f1uoxetine but none of thesedifferences reached statistical significance. Both treatment were welltolerated with no significant difference between treatment.

IP-12-171 Psychotropic Comedication and Adverse EventRates. Results froma Fluoxetine DrugSurveillance Study

RW. Dittmann I, M. Linden 2, M. Osterheider 3. I Univ. of Hamburg;Medical Dep., Lilly Germany, Bad Homburg, Germany; 2 Dep. ofPsychiatry, Univ. ofBerlin, Germany; 3 Dep. ofPsychiatry, Paderborn,Germany

Introduction: Studies with the SSRI Fluoxetine (Fix) under naturalisticconditions have been conducted in'Germany (1990 to 1993; N > 19.000).We report on 3.158 pats. treated by psychiatrists. Objective: comparisonof adverse event (AE) rates in pats. treated with Fix monotherapy (Flx­mono, N =1.571) vs. in those with psychotropic (l drug) comedication(PD; N = 737). Hypothesis: higher rate of AEs in comedicated pats.because of the well-known interactions between Fix and tricyclic antide­pressant and antipsychotic drugs (Cyt P450 2D6), and with tranquilizersas well.

Methods: Based on German scientific recommendations for drugsurveillance studies, data collection comprised: pal. characteristics, diag­noses. medication, comedication, efficacy, AEs (physicians' information).This analysis focussed on pat. characteristics and AE rates.

Results:Compared to Fix-mono the PD group showed: higher age (p <0.001), more pats. with endogenous and fewer with "neurotic" depression(p < 0.(01), with remittant or chronic course (p < 0.(01); more COlseverity (p < 0.001), higher Fix dose (p < 0.05); slightly more overallAE rates (PD: 26.7 vs. 23.5%), "serious" and "routine" (p :::0.10). SingleAEs matched the known Flx-AE-spectrum (nervousness, nausea < 7%,others < 2%).

Group differences were mainly accounted for by pats. with one an­tipsychotic co-medication (N = 128), e.g., more pats. with AEs (31.3 vs.23.5%, p = 0.06), "routine" and "serious". AE spectrum as known, EPS:tremor 1.6%, akathisia 0.8%.

Conclusion: Findings suggest that, under naturalistic conditions,comcdication of FIx with these compounds does not basically change thefavourable risklbenefit ratio of FIx use.

IP-12-181 Serotonergic (Fluoxetine) Versus Noradrenergic(Maprotiline) Antidepressants andSuicidality

M. Jakovljevic I, D. Vujic 2, N. Henigsberg 3. I University PsychiatricClinic Zagreb, Croatia; 2 Lek Pharmaceutical and ChemicalCompany,Ljubljana, Slovenia

Depression is commonly associated with suicidal thoughts and be­haviour. Effect of antidepressants on suicidality is of great importancefor outcome of antidepressant treatment.There are reports that selectiveserotonin reuptake inhibitors (SSRl) reduce suicidal ideas faster thanother antidepressants what is in line findings of correlation between lowcentral serotonin concentration and suicidal behaviour. On the other handsome authors reported the use of f1uoxetine (SSRI) might lead to theemergence or worsening of suicidal ideation, while the others reportedthat maprotiline (a noradrenaline uptake inhibitor) was associated greaterincidence of suicidal acts. To examine the relation between suicidalityand different types of antidepressant drugs, the, data week double blind,prospective, multicentre and multinational comparing ftuoxetine withmaprotiline were analysed.

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The database analysed comprised 98 patients of both sex with de­pressive episode, aged 40-65 years. 50 patients were treated ftuoxetine(20-40 mg/d) and 48 with maprotiline (75-150 mg/d); The global antide­pressant efficacy was comparable. A differentiated a? does not show anydifference in risk of suicidal acts between depressed patients treated withf1uoxetine and those treated with maprotiline. Analysis also failed to finddifference in beneficial effect on suicidality between these two drugs.

Outcomes Including Withdrawal PhenomenaDetected from a Naturalistic Comparison ofFluoxetine and Paroxetine Usedin the Treatmentof Affective Disorders in Patients with LearningDisabilities

S. Bhaumik, H.J. Wildgust. Frith Hospital, Leicester, U.K.

Randomised controlled clinical trials suggest that the efficacy and side ef­fects associated with f1uoxetine and paroxetine are very similar. However,naturalistic observations by Donaghue & Sclar suggest that in clinicalpractice there are differences which lead to higher costs associated withparoxetine. Similarly, randomised control trials have not shown with­drawal phenomena to be associated with SSRIs and they commented tharit occurred more commonly with paroxetine. However, the Committeeof Safety of Medicine have received a number of reports of withdrawalphenomena for SSRIs. Fava noted that this phenomena occurred in pa­tients who had had long-term exposure to paroxetine and sertraline andthis may explain why randomised controlled trials have failed to pick upthese events. We have, therefore, computed a very careful retrospectivecasenote analysis of the usage of both f1uoxetine and paroxetine in adultpatients with learning disabilities from Leicester, UK, who have receivedtreatment for depression/affective disorders in a three year period. In thereported data on efficacy, side-effects and withdrawal phenomenon ourstudy shows that, in clinical practice, both ftuoxetine and paroxetine havesimilar efficacy and side effect pattern but a higher discontinuation ratewas noted with paroxetine (8.8% f1uoxctine vs. 18% for paroxetine). Forfluoxetine there was no reported withdrawal phenomena but 42% of thepatients treated with paroxetine experienced withdrawal phenomena. Thesymptoms of antidepressant withdrawal is not documented in patientswith learning disabilities and we have reviewed differences in its pre­sentation from the general population. The value of this study is in itsaccurate reflection of clinical practice and, arguably, more effective anal­ysis of outcome (including drop-out rates, side-effects and withdrawalphenomena) than conventional clinical trial data.

IP-12-20 I Clinical Differences in Response to Mianserin andFluoxetine in Depressive Patients

F. Lavergne I, l. Berlin 2, C. Payan 2, G. Besancon 3. I OrganonLaboratory, France; 2 Pitie-Salpetriere hospital, France; 3 St Jacqueshospital, France

Aims: To compare the therapeutic effectiveness of mianserin and fluoxe­tine in patients with major depression and to characterize differences inclinical response. Patients aged 18 to 65 years with DSM III criteria fora depressive episode with a minimum score of 25 on the Montgomery­Asberg Depression Rating Scale (MADRS) were included. Design:Double-blind randomized trial mianserin versus ftuoxetine. Assessments:The depression was assessed at day 0, 14,28,56 by the MADRS and the«Mood-Anxiety-Retardation-Danger » diagram (HARD) [l]- Results:The 2 groups (mianserin n: 32; fluoxetine n: 33) were comparable forMADRS and HARD scores at baseline. Patients in the ftuoxetine group(46.3 ± Il.l years) were older than in the mianserin group (40.3 ± 11.4years) (p < 0.05). Global MADRS and HARD scores were comparableduring the 2 months of treatment (ANOYA for repeated measures). How­ever, when age of the patients was included in the analysis as covariable,the therapeutic effectiveness of mianserin (measured by the MADRSor HARD global scores) was higher than that of ftuoxetine (p =0.02for both scales). MADRS items « reduced sleep» (p < 0.0001) «concentration difficulties» (p =0.027) and « weariness» (p =0.02)improved better in the mianserin group than in the fluoxetine group. Inthe HARD scale « insomnia» (p < 0.0001), « weariness» (p =0.003), « anxiety factor» (p = 0.023) and « retardation factor» (p