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P.3.055 Fluoxetine in panic disorder: A placebo-controlled study
P3
Anxiety disorder~ and anxiolytics
E3.053: IES and the SCL-90 followingTMS (N = 10). Variablea Prior to TMS (B) 24 Hours after TMS. (I) Mean SD Mean SD CGI* 4.44 4- 1.1 2.89 4- 1.05 IES Total score IES-intrusion IES-avoidance SCL-90 Total score Depression Anxiety Interpersonal Sensitivity Somatization
2.77 4- 1.25 2.76 5:1.2 2.8 4- 1.4 2.1 4- 0.94 2.35 4- 0.94 2.37 4- 0.93 1.53 4- 1.0 2.3 4- 0.9
2.21 4- 1.18 2.66 ± 1.4 1.7 4- 1.12 1.85 4- 0.68 1.98 4- 0.72 1.75 4- 0.82 1.56 4- 0.81 1.84 4- 0.95
of avoidance, as well as anxiety and somatization and Clinical Global Impression. However, the effect was rather short and transient.
~
Fluoxetine in panic disorder: A placebo-controlled study
R.B. Lydiard 1, M.H. Pollack 2, R. Judge 3, D. Michelson a, R. Tamura a.
1University of S. Carolina; aMass. General Hospital, Boston," 3Eli Lilly & Co., Indianapolis, UK There is increasing evidence for the role of serotonin in panic disorder and this paper describes the results of a placebo-controlled study of fluoxetine, a selective serotonin uptake inhibitor, in the treatment of patients with this disorder. The study was of a multicentre, double-blind, randomised, parallel group design, comparing the efficacy and safety of two doses of fluoxetine (10 mg and 20 mg/day) with placebo. Eligible patients had to be suffering from panic disorder, with or without agoraphobia, and had to have experienced at least one panic attack in each of the 4 weeks preceding entry into the study. Patients with major depression or social phobia that was secondary and non-dominant could be included in the study. After a two week, single-blind, placebo lead-in phase, eligible patients were assigned to 10 weeks treatment with placebo (78 patients), fluoxetine 10 mg/day (84 patients) or fluoxetine 20 mg/day (8l patients). Efficacy measures included various assessments of Panic Attacks, Patient and Clinician-rated Panic and Phobic Disorder Scale changes, Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale-21 item (HAMD-21), Overall Phobia Rating Scale, Symptom Checklist-Revised (SCL-90-R), and Sheehan Disability Scale. An endpoint analysis was carried out assessing changes from baseline to last visit in the post-baseline period on a last-visit-carried-forward basis. There were no statistically significant differences between the treatment groups in baseline characteristics or baseline severity of illness. The efficacy analysis showed patients treated with fluoxetine 20 mg/day had a superior response compared with placebo as measured by the CGI (p = 0.024) as well as the patient global impression (p = 0.006). Fluoxetine was also superior to placebo across a range of other variables, indicating efficacy for a broad range of symptoms seen in panic disorder, for example: Average duration of Panic Attacks, Patient and Clinician-rated Change in Phobic Avoidance, Patient and Clinician-Rated Change in Clinical Global Impression-Improvement, Patient-rated Change in Panic Attacks, Patientrated Change in Anticipatory Anxiety, Patient-rated Change in Overall Functioning, Overall Phobia Rating Scale, HAMA and HAMD-21, Sheehart Disability Scale (Family Life Impaired) and SCL-90-R (Total Score, Somatization, Phobic Anxiety and Psychoticism). Fluoxetine l0 mg/day showed superiority over placebo for only a few of these assessments. Fluoxetine was well tolerated during this study and its efficacy in the treatment of patients with panic disorder was clearly demonstrated for the 20 mg/day dose. Improvements were seen both in parameters related to panic attacks and, importantly, for the comorbid symptoms of depression and anxiety.
$243
7 Days after TMS. (II) Mean SD 3.89 4- 0.93
28 Days after TMS. (lll) 28 Mean SD 4.55 4- 1.1
2.2 4- 1.28 2.8 4- 1.6 1.74 4- 0.94 1.95 4- I).93 2.2 4- 0.94 2.0 ± 0.85 1.6 4- 1.02 2.07 4- 1.06
2.6 4- 0.9 3.1 ± 0.1 2.08 ± 0.9 2.1 4- 0.82 2.3 4- 0.82 1.72 4- 0.73 1.72 ± 0.74 2.5 4- 0.78
[•
Significant Contrastsb B :~ I I # It, Ill NS NS B -7':I, It NS NS B y'=I, II1 NS B :~ I l -~i:Ill
Recognition and treatment of obsessive compulsive disorder in a pre-paid health plan: Does adequate treatment reduce costs?
L.M. Koran, J. Leventhal, B. Fireman, A. Jacobsen. Slanjbrd Universi~" Medical Center, Department of Psychiatry Stanford, CA; Kaiser Northern California Health Plan, USA Purpose: We studied the diagnosed prevalence, pharmacological treatment, medical care utilization and costs of patients with OCD in a large, pre-paid health plan. We wished to discover whether adequate OCD treatment reduces health care costs. M e t h o d s : The study population consists of 1.96 million members aged 6 or older enrolled continuously for 12 month,,;, 5/95 through 4/96, in a large pre-paid health plan, Kaiser Northern California. OCD diagnosis was captured from computerized forms recording each visit; chart reviews are underway to validate the diagnoses. We examined computerized records of OCD patients' annual psychiatric clinic utilization, rates of drug treatment, and nonpsychiatric medical care utilization. To compare OCD patients' utilization to that of health-plan members with a t psychiatric clinic visits, we calculated age-sex adjusted mean costs using ordinary least squares regression models. Results: The l-year prevalence of diagnosed OCD confirmed by chart review was 7.7/10,000 members, higher for adult females than for adult males, but lower for female children aged 6 to 17 than for male children. Of patients with confirmed OCD, 31% had 4 or more psychiatry clinic visits between 5/95 and 4/96. Of the OCD-confirmed patients, 62% had a _>8-week trial of a therapeutic dose of a serotonin reuptake inhibitor. Children aged 6 to 17 were less likely to have had an adequate trial (47%). Initial chart review results of those starting new ttials suggest that 29% were much better and 37% were somewhat better 8 to 12 weeks after starting a medication, and that the primary reasons for inadequate trials were adverse events (19%) and response at lower drug doses 114%). OCD patients had 63% higher mean annual costs for nonpsychiatric visits and 56% higher costs for laboratory and radiology services than patients with no psychiatric visits. Analyses are underway to compare the medical care costs of OCD patients with those of patients with depression and panic: disorder and to examine whether medical care costs decrease in the year after effective OCD treatment. C o n c l u s i o n s : The diagnosed prevalence of OCD is far lower than in community surveys, and substantial numbers of diagnosed patients have not received adequate drug trials. Whether adequate treatment saves health care dollars awaits further analysis.
I•
Buspirone as adjunctive treatment ot: chronic urticaria
F. Ser, M. Veljkovi~, M. Lazovi~, D. Marjanovid, S. Miiovanovi~. City
Departement for Skin and Venereal Diseases, Belgrade, Yugoslavia Urticaria may resylt from different causes. Psychic factor is also considered important. The aim of study was to determine, the efficasy of rather non sedating anxiolytic buspirone in the treatment of underlying anxiety in proffesions where strong sedative and hypnotic effect was contraindicated.
Anxiety disorder~ and anxiolytics
E3.053: IES and the SCL-90 followingTMS (N = 10). Variablea Prior to TMS (B) 24 Hours after TMS. (I) Mean SD Mean SD CGI* 4.44 4- 1.1 2.89 4- 1.05 IES Total score IES-intrusion IES-avoidance SCL-90 Total score Depression Anxiety Interpersonal Sensitivity Somatization
2.77 4- 1.25 2.76 5:1.2 2.8 4- 1.4 2.1 4- 0.94 2.35 4- 0.94 2.37 4- 0.93 1.53 4- 1.0 2.3 4- 0.9
2.21 4- 1.18 2.66 ± 1.4 1.7 4- 1.12 1.85 4- 0.68 1.98 4- 0.72 1.75 4- 0.82 1.56 4- 0.81 1.84 4- 0.95
of avoidance, as well as anxiety and somatization and Clinical Global Impression. However, the effect was rather short and transient.
~
Fluoxetine in panic disorder: A placebo-controlled study
R.B. Lydiard 1, M.H. Pollack 2, R. Judge 3, D. Michelson a, R. Tamura a.
1University of S. Carolina; aMass. General Hospital, Boston," 3Eli Lilly & Co., Indianapolis, UK There is increasing evidence for the role of serotonin in panic disorder and this paper describes the results of a placebo-controlled study of fluoxetine, a selective serotonin uptake inhibitor, in the treatment of patients with this disorder. The study was of a multicentre, double-blind, randomised, parallel group design, comparing the efficacy and safety of two doses of fluoxetine (10 mg and 20 mg/day) with placebo. Eligible patients had to be suffering from panic disorder, with or without agoraphobia, and had to have experienced at least one panic attack in each of the 4 weeks preceding entry into the study. Patients with major depression or social phobia that was secondary and non-dominant could be included in the study. After a two week, single-blind, placebo lead-in phase, eligible patients were assigned to 10 weeks treatment with placebo (78 patients), fluoxetine 10 mg/day (84 patients) or fluoxetine 20 mg/day (8l patients). Efficacy measures included various assessments of Panic Attacks, Patient and Clinician-rated Panic and Phobic Disorder Scale changes, Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale-21 item (HAMD-21), Overall Phobia Rating Scale, Symptom Checklist-Revised (SCL-90-R), and Sheehan Disability Scale. An endpoint analysis was carried out assessing changes from baseline to last visit in the post-baseline period on a last-visit-carried-forward basis. There were no statistically significant differences between the treatment groups in baseline characteristics or baseline severity of illness. The efficacy analysis showed patients treated with fluoxetine 20 mg/day had a superior response compared with placebo as measured by the CGI (p = 0.024) as well as the patient global impression (p = 0.006). Fluoxetine was also superior to placebo across a range of other variables, indicating efficacy for a broad range of symptoms seen in panic disorder, for example: Average duration of Panic Attacks, Patient and Clinician-rated Change in Phobic Avoidance, Patient and Clinician-Rated Change in Clinical Global Impression-Improvement, Patient-rated Change in Panic Attacks, Patientrated Change in Anticipatory Anxiety, Patient-rated Change in Overall Functioning, Overall Phobia Rating Scale, HAMA and HAMD-21, Sheehart Disability Scale (Family Life Impaired) and SCL-90-R (Total Score, Somatization, Phobic Anxiety and Psychoticism). Fluoxetine l0 mg/day showed superiority over placebo for only a few of these assessments. Fluoxetine was well tolerated during this study and its efficacy in the treatment of patients with panic disorder was clearly demonstrated for the 20 mg/day dose. Improvements were seen both in parameters related to panic attacks and, importantly, for the comorbid symptoms of depression and anxiety.
$243
7 Days after TMS. (II) Mean SD 3.89 4- 0.93
28 Days after TMS. (lll) 28 Mean SD 4.55 4- 1.1
2.2 4- 1.28 2.8 4- 1.6 1.74 4- 0.94 1.95 4- I).93 2.2 4- 0.94 2.0 ± 0.85 1.6 4- 1.02 2.07 4- 1.06
2.6 4- 0.9 3.1 ± 0.1 2.08 ± 0.9 2.1 4- 0.82 2.3 4- 0.82 1.72 4- 0.73 1.72 ± 0.74 2.5 4- 0.78
[•
Significant Contrastsb B :~ I I # It, Ill NS NS B -7':I, It NS NS B y'=I, II1 NS B :~ I l -~i:Ill
Recognition and treatment of obsessive compulsive disorder in a pre-paid health plan: Does adequate treatment reduce costs?
L.M. Koran, J. Leventhal, B. Fireman, A. Jacobsen. Slanjbrd Universi~" Medical Center, Department of Psychiatry Stanford, CA; Kaiser Northern California Health Plan, USA Purpose: We studied the diagnosed prevalence, pharmacological treatment, medical care utilization and costs of patients with OCD in a large, pre-paid health plan. We wished to discover whether adequate OCD treatment reduces health care costs. M e t h o d s : The study population consists of 1.96 million members aged 6 or older enrolled continuously for 12 month,,;, 5/95 through 4/96, in a large pre-paid health plan, Kaiser Northern California. OCD diagnosis was captured from computerized forms recording each visit; chart reviews are underway to validate the diagnoses. We examined computerized records of OCD patients' annual psychiatric clinic utilization, rates of drug treatment, and nonpsychiatric medical care utilization. To compare OCD patients' utilization to that of health-plan members with a t psychiatric clinic visits, we calculated age-sex adjusted mean costs using ordinary least squares regression models. Results: The l-year prevalence of diagnosed OCD confirmed by chart review was 7.7/10,000 members, higher for adult females than for adult males, but lower for female children aged 6 to 17 than for male children. Of patients with confirmed OCD, 31% had 4 or more psychiatry clinic visits between 5/95 and 4/96. Of the OCD-confirmed patients, 62% had a _>8-week trial of a therapeutic dose of a serotonin reuptake inhibitor. Children aged 6 to 17 were less likely to have had an adequate trial (47%). Initial chart review results of those starting new ttials suggest that 29% were much better and 37% were somewhat better 8 to 12 weeks after starting a medication, and that the primary reasons for inadequate trials were adverse events (19%) and response at lower drug doses 114%). OCD patients had 63% higher mean annual costs for nonpsychiatric visits and 56% higher costs for laboratory and radiology services than patients with no psychiatric visits. Analyses are underway to compare the medical care costs of OCD patients with those of patients with depression and panic: disorder and to examine whether medical care costs decrease in the year after effective OCD treatment. C o n c l u s i o n s : The diagnosed prevalence of OCD is far lower than in community surveys, and substantial numbers of diagnosed patients have not received adequate drug trials. Whether adequate treatment saves health care dollars awaits further analysis.
I•
Buspirone as adjunctive treatment ot: chronic urticaria
F. Ser, M. Veljkovi~, M. Lazovi~, D. Marjanovid, S. Miiovanovi~. City
Departement for Skin and Venereal Diseases, Belgrade, Yugoslavia Urticaria may resylt from different causes. Psychic factor is also considered important. The aim of study was to determine, the efficasy of rather non sedating anxiolytic buspirone in the treatment of underlying anxiety in proffesions where strong sedative and hypnotic effect was contraindicated.