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Treatment of panic disorder with paroxetine
Poster session I
the underlying depression Is not effectively tackled. The pathogenesis of both anxiety and depression involves abnormalities In serotonergic transmitter systems and the frequent comorbldlty of these disorders has stimulated Interest In the use of the selective serotonin reuptake inhibitors In comorbid patients.
114-41
I Treatment of panic disorder with paroxetine
I. Gergel' , O. Bumham " R. Kumar 2 • ' SmithKline Beecham Pharmaceuticals, Collegeville, PA, USA, 2 SmithKline Beecham Pharmaceuticals, New Frontiers Science Park, Harlow, UK Panic disorder Is a chronic Illness, often associated with comorbid ago• raphobia, depression and anxiety which lead to considerable disability in social functioning. Paroxetlne is currently the only selective serotonin reup• take Inhibitor approved for the treatment of panic disorder; Its efficacy and safety has been assessed In an extensive clinical trial programme Including > 1000 patients. In a short-term study Involving 120 patients, the proportion of responders (reduction In the number of panic attacks to 1 or 0) In the paroxetine group was significantly greater (36%) than In the placebo group (16%) [p < 0.05) after 12 weeks. In a second short-term study involving 367 patients, 51% of patients receiving paroxetlne were free from panic attacks aller 9 weeks' treatment, compared with 37% receiving clomipramine (p < 0.05) and 32% In the placebo group (p < 0.005). The proportion of patients free of panic attacks In the paroxetine group continued to rise to a maximum of 65% aller 12 months. This was significantly higher than placebo (59%; p < 0.005) and greater than clomipramine (72%). In a relapse prevention study, those who continued to take paroxetlne had a significantly (p .. 0.002) lower relapse rate (5%) than those who were changed to placebo (30%). Nausea and sweating were the most frequently reported adverse events. Significantly (p .. 0.02) more patients with adverse events were reported In the clomipramine group compared with paroxetine during short-term treat· ment Paroxetine therefore provides effective treatment for panic disorder, maintained over long-term treatment, and may be better tolerated than clomipramine.
114-421
Patient disability In panic disorder
I. Gergel', O. Bumham " R. Kumar 2. ' SmithKline Beecham
Pharmaceuticals, Collegeville, PA, USA, 2 SmithKline Beecham Pharmaceuticals, New Frontiers Science Park, Harlow, UK
Panic disorder Is associated with considerable disability In social functioning. The level of disability can be measured using scales which monitor how much symptoms disrupt work, social life and family life. The results of two clinical studies which assessed disability In patients with panic disorder before and after treatment with paroxetine are reported here. The Shee• han Disability Scale (SOS) was used to measure disability during short• and long-term treatment in a placebo-controlled study of paroxetine and clomipramine. Mean scores at baseline were similar for the three groups and ranged from 5.2 (SO ± 2.6) to 6.3 (SO ± 2.5), equivalent to moderate disruption. The scores improved with time and the Improvement in both active treatment groups was significantly greater than placebo (p < 0.05). The improvement in scores was coincident with a reduction in the frequency of panic attacks and was maintained long term. After 12 months' treatment mean SOS scores for paroxetine patients were between 1 and 2, equivalent to mild disruption. Similar results were reported in a dose response study where after 10 weeks' treatment with paroxetine there was a reduction In the frequency of panic attacks and reduced disability as measured by SDS and Social Adjustment Self-report Questionnaire (SAQ) scores. In an extension of this study in which patients were re-randomlsed, patients who switched from paroxetine to placebo experienced a sharp Increase in panic attacks and a concomitant increase In SAQ scores. In conclusion, paroxe• tine treatment can produce a rapid and sustained reduction in the frequency 01 panic attacks and Improvement In the disability associated with panic disorder. 1
14-43 1 Season of birth in panic disorder
BIOL. PSYCHIATRY 1997:42:1S-297S
29S
affective, neurotic and personality disorders; the results, however, are much less consistent than In schizophrenia. Two epidemiological studies on manic or bipolar patients revealed a significant excess of births in the first quarter on the year. The seasonality of birth In alcoholics has only sporadically been stUdied. The aim of our study was to verify if there Is a specific distribution by month of birth In subjects with Panic Disorder (PO). We compared the birth months of 438 patients with PO with the birth months of 451 SUbjects with other mental diseases without PO in comorbldity. All patients were bom beetwen 1925 and 1982. Significant differences were found between the two groups. The monthly distribution of birth in patients with PD (With and without comorbldlty) peaked more clearly in September to December, while any relevant deviation In birth rates was observed In the control group. Can birth date contribute to the development of PO?
114-441
Physiopathologic hypothesis for panic attacks
X. Fluvia, M. Rodriguez. U.S.M. de Calp, Alacant, Servel ValenciA de Salut, Spain Many disorders may break out panic attack crisis and usually are serious diseases: cardiovascular, pulmonary, neurologic or endocrine disorders, psychostimulants abuse, sedative withdrawal, some psychiatric illnesses and many other conditions. Nevertheless, some panic attacks are not related to other disorders except for, some times, genetic factors, stressful life events or some disorders of psychological development. We also must bear In mind that C02 Inhalation or endovenous lactate infusion usually break out panic attacks In patients with panic disorder but not In the same people when they are healthy. Conclusion: There are many disorders that may lead directly to a panic attack. And perhaps, many others need to be repeated several times or lots of times to finally break out the panic attack, that is the Kindling phenomenon.
114-451
Temperament and character dimensions of fluvoxamlne responder panic disorder patients
G. Faludl, K. Tekes, I. Jekl. Department of Psychiatry. Semmelweis University of Medicine, Hungary Panic disorder (PD) is often accompanied by such disturbances of mood and character that do not respond to conventional drug therapy. It seems likely that one of the "dynamic engines" of PO-similarly to other mental disorders-is the personality Itself. Genetically determined personality dimensions seem to play an Important role In not only shaping the nature of the disorder, but In affecting the response to therapy as well. The aim of our present study was to determine charecterlstic personality dimensions that may predict the outcome of drug therapy In PO patients. 23 PO patients (9 male, 14 female, 18-60 years) on fluvoxamine who have been symptom free for at least 6 months were evaluated. At the beginning of the treatment temperament and character dimensions were determined by the Temperament and Char• acter Inventory (TCI, Cloninger et. at) and personality clusters (DSM-IV.) were determined by the SZEM·63 questionaire. Platelet rich plasma (PRP) serotonin content was determined by HPLC-EC method on the 1. day and after 3 and 6 months of treatment. The TCI showed that '1larm avoidance" and "reward dependence" are the most frequent temperament dimensions, while "novelty seeking" Is the most infrequent one in this group of patients. It was found that cluster "C" and specifically the avoidant personality type was the most common among the f1uvoxamlne responder PO patients. PRP serotonin content was found to be in negative correlation with f1uvoxamlne treatment. PO patients characterized by '1larm avoidant" and "reward de• pendent" temperament dimensions show excellent response to f1uvoxamlne therapy. It also concluded, that PRP serotonin content measurement offers a sensitive and reliable method for monitoring compliance.
114-461
Response to pharmacological treatment of psychosensorial symptoms In patients with panic disorder
S. lapichlno, F. Pieraccini, A. 01 Muro, M. Del sole, P. Castrogiovannl. Department of Psychiatry. University of Siena, Italy
C. Toni, S. Ramacciottl, B. Simonetti, E. De Soricellis, T. Xuereb, H.B. Mata, G. Perugi. Clinica Psichiatrica dI Pisa. Italy
Several data about the seasonal distrubutlon by months of birth of patients suffering from schizophrenia, are according with the winter-sprlng birth rate excess. The few studies conducted on other mental disorders are focused on
Feelings of derealization and depersonalization (DO) are usually associated with high levels of anxiety and they are described In about 30".4 of patients with Panic Disorder (PO).
the underlying depression Is not effectively tackled. The pathogenesis of both anxiety and depression involves abnormalities In serotonergic transmitter systems and the frequent comorbldlty of these disorders has stimulated Interest In the use of the selective serotonin reuptake inhibitors In comorbid patients.
114-41
I Treatment of panic disorder with paroxetine
I. Gergel' , O. Bumham " R. Kumar 2 • ' SmithKline Beecham Pharmaceuticals, Collegeville, PA, USA, 2 SmithKline Beecham Pharmaceuticals, New Frontiers Science Park, Harlow, UK Panic disorder Is a chronic Illness, often associated with comorbid ago• raphobia, depression and anxiety which lead to considerable disability in social functioning. Paroxetlne is currently the only selective serotonin reup• take Inhibitor approved for the treatment of panic disorder; Its efficacy and safety has been assessed In an extensive clinical trial programme Including > 1000 patients. In a short-term study Involving 120 patients, the proportion of responders (reduction In the number of panic attacks to 1 or 0) In the paroxetine group was significantly greater (36%) than In the placebo group (16%) [p < 0.05) after 12 weeks. In a second short-term study involving 367 patients, 51% of patients receiving paroxetlne were free from panic attacks aller 9 weeks' treatment, compared with 37% receiving clomipramine (p < 0.05) and 32% In the placebo group (p < 0.005). The proportion of patients free of panic attacks In the paroxetine group continued to rise to a maximum of 65% aller 12 months. This was significantly higher than placebo (59%; p < 0.005) and greater than clomipramine (72%). In a relapse prevention study, those who continued to take paroxetlne had a significantly (p .. 0.002) lower relapse rate (5%) than those who were changed to placebo (30%). Nausea and sweating were the most frequently reported adverse events. Significantly (p .. 0.02) more patients with adverse events were reported In the clomipramine group compared with paroxetine during short-term treat· ment Paroxetine therefore provides effective treatment for panic disorder, maintained over long-term treatment, and may be better tolerated than clomipramine.
114-421
Patient disability In panic disorder
I. Gergel', O. Bumham " R. Kumar 2. ' SmithKline Beecham
Pharmaceuticals, Collegeville, PA, USA, 2 SmithKline Beecham Pharmaceuticals, New Frontiers Science Park, Harlow, UK
Panic disorder Is associated with considerable disability In social functioning. The level of disability can be measured using scales which monitor how much symptoms disrupt work, social life and family life. The results of two clinical studies which assessed disability In patients with panic disorder before and after treatment with paroxetine are reported here. The Shee• han Disability Scale (SOS) was used to measure disability during short• and long-term treatment in a placebo-controlled study of paroxetine and clomipramine. Mean scores at baseline were similar for the three groups and ranged from 5.2 (SO ± 2.6) to 6.3 (SO ± 2.5), equivalent to moderate disruption. The scores improved with time and the Improvement in both active treatment groups was significantly greater than placebo (p < 0.05). The improvement in scores was coincident with a reduction in the frequency of panic attacks and was maintained long term. After 12 months' treatment mean SOS scores for paroxetine patients were between 1 and 2, equivalent to mild disruption. Similar results were reported in a dose response study where after 10 weeks' treatment with paroxetine there was a reduction In the frequency of panic attacks and reduced disability as measured by SDS and Social Adjustment Self-report Questionnaire (SAQ) scores. In an extension of this study in which patients were re-randomlsed, patients who switched from paroxetine to placebo experienced a sharp Increase in panic attacks and a concomitant increase In SAQ scores. In conclusion, paroxe• tine treatment can produce a rapid and sustained reduction in the frequency 01 panic attacks and Improvement In the disability associated with panic disorder. 1
14-43 1 Season of birth in panic disorder
BIOL. PSYCHIATRY 1997:42:1S-297S
29S
affective, neurotic and personality disorders; the results, however, are much less consistent than In schizophrenia. Two epidemiological studies on manic or bipolar patients revealed a significant excess of births in the first quarter on the year. The seasonality of birth In alcoholics has only sporadically been stUdied. The aim of our study was to verify if there Is a specific distribution by month of birth In subjects with Panic Disorder (PO). We compared the birth months of 438 patients with PO with the birth months of 451 SUbjects with other mental diseases without PO in comorbldity. All patients were bom beetwen 1925 and 1982. Significant differences were found between the two groups. The monthly distribution of birth in patients with PD (With and without comorbldlty) peaked more clearly in September to December, while any relevant deviation In birth rates was observed In the control group. Can birth date contribute to the development of PO?
114-441
Physiopathologic hypothesis for panic attacks
X. Fluvia, M. Rodriguez. U.S.M. de Calp, Alacant, Servel ValenciA de Salut, Spain Many disorders may break out panic attack crisis and usually are serious diseases: cardiovascular, pulmonary, neurologic or endocrine disorders, psychostimulants abuse, sedative withdrawal, some psychiatric illnesses and many other conditions. Nevertheless, some panic attacks are not related to other disorders except for, some times, genetic factors, stressful life events or some disorders of psychological development. We also must bear In mind that C02 Inhalation or endovenous lactate infusion usually break out panic attacks In patients with panic disorder but not In the same people when they are healthy. Conclusion: There are many disorders that may lead directly to a panic attack. And perhaps, many others need to be repeated several times or lots of times to finally break out the panic attack, that is the Kindling phenomenon.
114-451
Temperament and character dimensions of fluvoxamlne responder panic disorder patients
G. Faludl, K. Tekes, I. Jekl. Department of Psychiatry. Semmelweis University of Medicine, Hungary Panic disorder (PD) is often accompanied by such disturbances of mood and character that do not respond to conventional drug therapy. It seems likely that one of the "dynamic engines" of PO-similarly to other mental disorders-is the personality Itself. Genetically determined personality dimensions seem to play an Important role In not only shaping the nature of the disorder, but In affecting the response to therapy as well. The aim of our present study was to determine charecterlstic personality dimensions that may predict the outcome of drug therapy In PO patients. 23 PO patients (9 male, 14 female, 18-60 years) on fluvoxamine who have been symptom free for at least 6 months were evaluated. At the beginning of the treatment temperament and character dimensions were determined by the Temperament and Char• acter Inventory (TCI, Cloninger et. at) and personality clusters (DSM-IV.) were determined by the SZEM·63 questionaire. Platelet rich plasma (PRP) serotonin content was determined by HPLC-EC method on the 1. day and after 3 and 6 months of treatment. The TCI showed that '1larm avoidance" and "reward dependence" are the most frequent temperament dimensions, while "novelty seeking" Is the most infrequent one in this group of patients. It was found that cluster "C" and specifically the avoidant personality type was the most common among the f1uvoxamlne responder PO patients. PRP serotonin content was found to be in negative correlation with f1uvoxamlne treatment. PO patients characterized by '1larm avoidant" and "reward de• pendent" temperament dimensions show excellent response to f1uvoxamlne therapy. It also concluded, that PRP serotonin content measurement offers a sensitive and reliable method for monitoring compliance.
114-461
Response to pharmacological treatment of psychosensorial symptoms In patients with panic disorder
S. lapichlno, F. Pieraccini, A. 01 Muro, M. Del sole, P. Castrogiovannl. Department of Psychiatry. University of Siena, Italy
C. Toni, S. Ramacciottl, B. Simonetti, E. De Soricellis, T. Xuereb, H.B. Mata, G. Perugi. Clinica Psichiatrica dI Pisa. Italy
Several data about the seasonal distrubutlon by months of birth of patients suffering from schizophrenia, are according with the winter-sprlng birth rate excess. The few studies conducted on other mental disorders are focused on
Feelings of derealization and depersonalization (DO) are usually associated with high levels of anxiety and they are described In about 30".4 of patients with Panic Disorder (PO).