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Sertraline in continuation therapy
P Poster Presentations
124 nausea (24.7%), headache (24.7%) and diarrhea/loose stools (16.0%)' ('p < 0.05 between treatments). Adverse events were mostly moderate or mild causing few patients (16.7% clomipramine and I I. I% sertraline) to withdraw. The results indicate that sertraline was as effective as clomipramine but better tolerated in the management of severe major depression.
I P-12-121
The Efficacy of Sertraline in the Treatment of MajorDepression
D. Bugarski-Kirola, A. Damjanovic, V.R. Paunovic, Dj. Zivkovic, Z. Stankovic, Institute for Psychiatry, UCC, Belgrade, YUGOSLAVIA The efficacy of sertraline in the treatment of major depression was investigated in an open study.30 female inpatients (age 35-56) who were diagnosed as major depression according to the DSM III R criteria were subsequently includedin this study. HAMD-17 itemand COl ratingscales were used for the assessmentof the severity of symptoms and the efficacy of treatment. The patients were rated as baseline, 3-7 days after the wash-out period, and weekly for six weeks of treatment. Sertraline was administered in the averagedoses 50-100 mg once a day. After six weeks of treatment,23 patients(77%) demonstrated a decrease greaterthan50% in total HAMD score compared to baseline, and significant improvement on CGI scale was also noticed in 26 patients (86%) (responder rates I or 2). 2 patients were forced to discontinue the treatment because of the appearance of serious infection, and other two dropped out from the study because of the reasons not related to the treatment. Although this was an open study on a relatively small sampleof patientsthe efficacy of sertraline in the treatment of major depression was confirmed. In terms of tolerability and side-effects, 5 patients complained of headache and gastrintestinal discomfort during the first week of treatment. Hypnotics were the only concomitantdrugs used.
I P-12-13!
Sertraline in Continuation Therapy
S. Montgomery I, R. Lane 2. ] Department of Psychiatry, St. Mary's Hospital Medical School, London, UK; 2 Pfizer lnc., New York, USA After initial resolution of the acute depressive symptoms it appears that patients remain vulnerable to a return of their depression and if antidepressant treatment is discontinued too soon relapse of the symptoms is likely. A continuation phase of therapy to prevent relapse, (i.e., re-emergence of the index episode of depression) typically extends 4-6 months after resolution of symptoms. In the prevention of relapse of depression, following 8 weeksof acuteopen-label sertraline treatment for majordepression, sertralinehas demonstrated superiorefficacy to placebo with relapse (becoming and remaining moderately ill on COl-S) rates in the subsequent4-month periodof 18.5%in sertraline-treated patientsand 44.5% in placebo-treated patients [I] and this has been supported by open studies of acute and continuation treatment [2]. In comparative studies of 6 months or more, sertraline has demonstrated equivalent efficacy to fluoxetine [3], and superiorefficacy to imipramine r4] in out-patients with major depression. In a 6 month placebo controlled study in depressed patients in primary care, superior efficacy was demonstrated over mianserin [5]. A consistent finding of all sertraline studies in depression of 6 months or more is the continuing reduction in depressive and anxiety symptomatology in the sertraline-treated patients over the entire course of the study. [I] Montgomery et al.lotClin Psychophannacol 6 (1991) 37-46 [2] Floris Met at.EurNeuropsychophannacol 5 (1995) 308 [3] Van Moffaert M.Hum Psychophannacol (inpress) [4] Fontaine R etal. J Eur Col Psychopharmacol 3 (1991) 447 [5] Malt U. EurNeuropsychopharmacol5 (1995) 288-9
I P-12-141
Sexual Side Effects during Sertraline Treatment of Patients with MayorDepression: A Naturalistic Study A. Lista Varela. A Psychoneuropharmacology Unit, School of Medicine, Montevideo, Uruguay
There are insufficient data regarding sexual side effects of SSRIs used in
the clinical context. Sexual dysfunction has been reported between 5 to 15%of patients treatedwith SSRIs in premarketing trials. However, more recentreportsestimatea prevalence between35 to 75%. In order to investigatethese claims, the effects of sertralineon sexual function of patients with mayor depression (DSM-III-R) were examined in a retrospective naturalistic study of 112 subjects treated between 1993 (July) to 1995 (Set). Chart review of patientswith more than 8 weeks on sertraline were included. 112 (18-65; 42.3 ± 20.5 years) subjects (71 women, 42 men) were on sertraline at least for 8 weeks, 82 (47 women, 35 men) of these patients have been treated for more than 8 weeks (35.2 ± 18.6 weeks). No patient discontinued treatment due to sexual side effects. The most frequent sexual side effect reported was "more time reaching orgasm", 18%, and was similar in both sexes. Anorgasmia was reported in 5% of men and 1% of women. 23% of the total group reported some type of sexual dysfunction, without differences between sexes. There were no differences associated with time of treatment. Sertraline induced an improvement in sexual performance of mayor depression patients in this sample as suggested by the item 6 of SDS: 3.8 ± 0.5 (baseline), 2.1 ± 1.2 (8 w) and 1.8 ± 0.9 (>8 w). In conclusion, the prevalence of sexual side effects with sertraline were no so high as reported with other SSRIs. These effects were well tolerated and no interfere with the adherence to treatment.
I P-12-151 A Six Month Comparison of Toleration and Efficacy of Sertraline and Fluoxetine Treatment of Major Depression P.R. Latimer I, A.V. Ravindran I, J.-P. Bematchez I, J.-P. Fournier I, J.A. Gojer I, K Barratt 2, J. Buttars 2. I Canadian Psychiatry Centers; 2
Pfizer Canada, Kirkland, Canada
In a double-blind, parallel-group, multicenter study of major depression, the efficacy and safety of sertraline (STL) versus fluoxetine (FLU) treatment were compared during six months of therapy. Fifty-four and 52 outpatients were randomly allocated to receive 50 mg of STL or 20 mg of FLU respectively once daily for 4 weeks, followed by an 8 week dose-titration phase and 12 weeks of continuation therapy. Efficacy was assessed in 49 STL and 47 FLU patients using the Hamilton Rating Scale for Depression and Anxiety, Montgomery Asberg Depression Rating Scale, Leeds Sleep Evaluation Scale, Hopkins Symptom Checklist (SCL-58), the severity and improvement scales of the Clinical Global Impression and the BatelleQualityof Life Questionnaire. On all measures of efficacy, there was significant improvement from baseline to the last visit in both treatments, with significant changesevident by the first week of treatment. A significant amelioration in quality of life was observed in both treatment groups by the final study visit. Clinical improvements were sustained throughout the continuation phase with no relapses. No significant group differences in efficacy were found, although a trend for greater improvement in STL over FLU patients was observed on the SCL-58 anxiety scale (p < 0.06). Adverse events in both groups were predominantly gastrointestinal complaints and headaches, with a higher prevalence of dyspepsia (p < 0.05) in STL patients and dermatological side effects (p < 0.05) in FLU patients. Significant weight loss was observed in FLU (p < 0.05), but not in STL patients. In conclusion, both STL and FLU were well tolerated and equally efficacious in the acute and continuation treatmentof majordepression, with differences between treatments occurring primarily in the side effect profileand weight loss.
IP-12-16! AFluoxetine Double Blind Comparison of Sertraline and in the Treatment of MajorDepressive Episode in Out Patient D. Sechter I, S. Troy2, P. Rioux. I Department ofPsychiatry and Medical Psychology, CHU Saint-Jacques, Besancon, France; 2 Pfizer, Orsay, France
Efficacy-safety and effects on quality of live of sertraline (50, 100 and 150mg) was comparedto fluoxetine (20, 40 and 60 mg) in a multicentric studyof out patientswith majordepressive episode (DSM III-R). Patients were randomly assignedto one of the 2 treatmentgroups and treatedwith flexible dose for six months with either sertraline (N '= 117)or fluoxetine (N =119). Patientswere assessed monthlywith HAMD,HAD, COVI for
124 nausea (24.7%), headache (24.7%) and diarrhea/loose stools (16.0%)' ('p < 0.05 between treatments). Adverse events were mostly moderate or mild causing few patients (16.7% clomipramine and I I. I% sertraline) to withdraw. The results indicate that sertraline was as effective as clomipramine but better tolerated in the management of severe major depression.
I P-12-121
The Efficacy of Sertraline in the Treatment of MajorDepression
D. Bugarski-Kirola, A. Damjanovic, V.R. Paunovic, Dj. Zivkovic, Z. Stankovic, Institute for Psychiatry, UCC, Belgrade, YUGOSLAVIA The efficacy of sertraline in the treatment of major depression was investigated in an open study.30 female inpatients (age 35-56) who were diagnosed as major depression according to the DSM III R criteria were subsequently includedin this study. HAMD-17 itemand COl ratingscales were used for the assessmentof the severity of symptoms and the efficacy of treatment. The patients were rated as baseline, 3-7 days after the wash-out period, and weekly for six weeks of treatment. Sertraline was administered in the averagedoses 50-100 mg once a day. After six weeks of treatment,23 patients(77%) demonstrated a decrease greaterthan50% in total HAMD score compared to baseline, and significant improvement on CGI scale was also noticed in 26 patients (86%) (responder rates I or 2). 2 patients were forced to discontinue the treatment because of the appearance of serious infection, and other two dropped out from the study because of the reasons not related to the treatment. Although this was an open study on a relatively small sampleof patientsthe efficacy of sertraline in the treatment of major depression was confirmed. In terms of tolerability and side-effects, 5 patients complained of headache and gastrintestinal discomfort during the first week of treatment. Hypnotics were the only concomitantdrugs used.
I P-12-13!
Sertraline in Continuation Therapy
S. Montgomery I, R. Lane 2. ] Department of Psychiatry, St. Mary's Hospital Medical School, London, UK; 2 Pfizer lnc., New York, USA After initial resolution of the acute depressive symptoms it appears that patients remain vulnerable to a return of their depression and if antidepressant treatment is discontinued too soon relapse of the symptoms is likely. A continuation phase of therapy to prevent relapse, (i.e., re-emergence of the index episode of depression) typically extends 4-6 months after resolution of symptoms. In the prevention of relapse of depression, following 8 weeksof acuteopen-label sertraline treatment for majordepression, sertralinehas demonstrated superiorefficacy to placebo with relapse (becoming and remaining moderately ill on COl-S) rates in the subsequent4-month periodof 18.5%in sertraline-treated patientsand 44.5% in placebo-treated patients [I] and this has been supported by open studies of acute and continuation treatment [2]. In comparative studies of 6 months or more, sertraline has demonstrated equivalent efficacy to fluoxetine [3], and superiorefficacy to imipramine r4] in out-patients with major depression. In a 6 month placebo controlled study in depressed patients in primary care, superior efficacy was demonstrated over mianserin [5]. A consistent finding of all sertraline studies in depression of 6 months or more is the continuing reduction in depressive and anxiety symptomatology in the sertraline-treated patients over the entire course of the study. [I] Montgomery et al.lotClin Psychophannacol 6 (1991) 37-46 [2] Floris Met at.EurNeuropsychophannacol 5 (1995) 308 [3] Van Moffaert M.Hum Psychophannacol (inpress) [4] Fontaine R etal. J Eur Col Psychopharmacol 3 (1991) 447 [5] Malt U. EurNeuropsychopharmacol5 (1995) 288-9
I P-12-141
Sexual Side Effects during Sertraline Treatment of Patients with MayorDepression: A Naturalistic Study A. Lista Varela. A Psychoneuropharmacology Unit, School of Medicine, Montevideo, Uruguay
There are insufficient data regarding sexual side effects of SSRIs used in
the clinical context. Sexual dysfunction has been reported between 5 to 15%of patients treatedwith SSRIs in premarketing trials. However, more recentreportsestimatea prevalence between35 to 75%. In order to investigatethese claims, the effects of sertralineon sexual function of patients with mayor depression (DSM-III-R) were examined in a retrospective naturalistic study of 112 subjects treated between 1993 (July) to 1995 (Set). Chart review of patientswith more than 8 weeks on sertraline were included. 112 (18-65; 42.3 ± 20.5 years) subjects (71 women, 42 men) were on sertraline at least for 8 weeks, 82 (47 women, 35 men) of these patients have been treated for more than 8 weeks (35.2 ± 18.6 weeks). No patient discontinued treatment due to sexual side effects. The most frequent sexual side effect reported was "more time reaching orgasm", 18%, and was similar in both sexes. Anorgasmia was reported in 5% of men and 1% of women. 23% of the total group reported some type of sexual dysfunction, without differences between sexes. There were no differences associated with time of treatment. Sertraline induced an improvement in sexual performance of mayor depression patients in this sample as suggested by the item 6 of SDS: 3.8 ± 0.5 (baseline), 2.1 ± 1.2 (8 w) and 1.8 ± 0.9 (>8 w). In conclusion, the prevalence of sexual side effects with sertraline were no so high as reported with other SSRIs. These effects were well tolerated and no interfere with the adherence to treatment.
I P-12-151 A Six Month Comparison of Toleration and Efficacy of Sertraline and Fluoxetine Treatment of Major Depression P.R. Latimer I, A.V. Ravindran I, J.-P. Bematchez I, J.-P. Fournier I, J.A. Gojer I, K Barratt 2, J. Buttars 2. I Canadian Psychiatry Centers; 2
Pfizer Canada, Kirkland, Canada
In a double-blind, parallel-group, multicenter study of major depression, the efficacy and safety of sertraline (STL) versus fluoxetine (FLU) treatment were compared during six months of therapy. Fifty-four and 52 outpatients were randomly allocated to receive 50 mg of STL or 20 mg of FLU respectively once daily for 4 weeks, followed by an 8 week dose-titration phase and 12 weeks of continuation therapy. Efficacy was assessed in 49 STL and 47 FLU patients using the Hamilton Rating Scale for Depression and Anxiety, Montgomery Asberg Depression Rating Scale, Leeds Sleep Evaluation Scale, Hopkins Symptom Checklist (SCL-58), the severity and improvement scales of the Clinical Global Impression and the BatelleQualityof Life Questionnaire. On all measures of efficacy, there was significant improvement from baseline to the last visit in both treatments, with significant changesevident by the first week of treatment. A significant amelioration in quality of life was observed in both treatment groups by the final study visit. Clinical improvements were sustained throughout the continuation phase with no relapses. No significant group differences in efficacy were found, although a trend for greater improvement in STL over FLU patients was observed on the SCL-58 anxiety scale (p < 0.06). Adverse events in both groups were predominantly gastrointestinal complaints and headaches, with a higher prevalence of dyspepsia (p < 0.05) in STL patients and dermatological side effects (p < 0.05) in FLU patients. Significant weight loss was observed in FLU (p < 0.05), but not in STL patients. In conclusion, both STL and FLU were well tolerated and equally efficacious in the acute and continuation treatmentof majordepression, with differences between treatments occurring primarily in the side effect profileand weight loss.
IP-12-16! AFluoxetine Double Blind Comparison of Sertraline and in the Treatment of MajorDepressive Episode in Out Patient D. Sechter I, S. Troy2, P. Rioux. I Department ofPsychiatry and Medical Psychology, CHU Saint-Jacques, Besancon, France; 2 Pfizer, Orsay, France
Efficacy-safety and effects on quality of live of sertraline (50, 100 and 150mg) was comparedto fluoxetine (20, 40 and 60 mg) in a multicentric studyof out patientswith majordepressive episode (DSM III-R). Patients were randomly assignedto one of the 2 treatmentgroups and treatedwith flexible dose for six months with either sertraline (N '= 117)or fluoxetine (N =119). Patientswere assessed monthlywith HAMD,HAD, COVI for