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Sequential studies of the treatment of mania
618
Abstracts
mOL PSYCHIATRY 1996;39:500-666
nonnalized following improvement In depressive symptoms. The results of this study provide strong support for the role of the sel"Olonergic syslem in the pathopbysiology of seasonal affective disorder and in the mechanism of :lclion of light ther.lpy.
Who dccompensatcd while on placebo. bOlh have subsequently "respond. cd" to open-label scrtraline. The sixth palient, who dropped out. was nl80 on active sertraline nnd WilS improved at her last appointment. Preliminary findings from this ongoing study indicate Ihal scnraline may be efficacious in the treatment of poslpartum depression. Detailed results including comorbid diagnoses. severity of depression and personal and family psychialric history will be presented.
406. BROFAROMINE IN SOCIAL PHOBIARECENT FINDINGS FROM A US TRIAL R.J. Katz, M. Lou, & the Brofaromine Investigator's Group* eNS. Medical and Cliniclll Developmcnt. elBA Pharmnceuticuls. Summit. NJ 07901
Brofaromine is il selective and reversible MAO·A inhibitor with S·HT uptake inhibitory properties. Brofaromine Protocol 04 was a ramJomizcd. double-blind parallel-placebo trial. Patients with DSM m·R diagnosed social phobin were studied for 12 wcc:ks at doses of 100-150 mg/d. One hundred six patienls were randomized and 102 supplied efficacy data. Mean LSPS scores on entry for broraromine nod placebo were approximately 80. Visit T difference scores for drug and placebo were 62.6 and 10.7 respectively (p<.029). Physician Global ratings tcnded 10 covary with social phobia scores. These findings are consistent with IWO previous European trials (Van Vlir.t, Fahlcn) indicating significant effects of Brofarominc in social phobia. •J. Ballengt:f, P. Bohn. B. Diamond. A. Feiger.l. Greist, R. Landbloom. T. Mellman, D. Muniack. P. Ninan, W. Pettie, E. Reiman, & P. Tucker
407. CONTROLLED STUDY OF ANTIDEPRESSANT TREATMENT OF POSTPARTUM DEPRESSION C.N. Epperson, C,J. McDougle, D. Ward-O'Brien, & L.H. Price
408. SEQUENTIAL STUDIES OF THE TREATMENT OF MANIA 1.G. Small, M.H. Klapper, V. Milstein, J,D. Marhenke, & I.F. Small Department of Psychiatry, Indiana UniversilY School of Medicine. Indianapolis. IN; Larue D. Carter Memorial Hospital. 1315 W. 10th SI., Indianapolis. IN 46202 Between 1980 and 1995 a. series of therapeutic trials involving 130 bipolar I manic palients was conducled ut a single facility. Ench lrial consisted of comparisons of lithium with various other therapeulic lIgents alone or in combination including ECf. carbamazepinc. haloperidol and rispcridone. AU studies involved standard diagnostic interviews and similar research designs with two weeks of drug washOUI followed by 8 weeks of randomized or arbitrarily a.~signed treatment with weekly standard ratings of psychopalhology. Data from the above trials were pooled 10 assess comparative efficacy a.nd side effects. No clinically important baseline differences were found despite lhe 15 yetlt time span. Palienls wC'r~ no~ o-~crly "difficult to Ireat" or treatment resistant and most were dischnrgedto the community. Outcome after eight weeks was best in the ECT patienls followed by those assigned 10 lithium combined with tow do~s of standard ncuroleptics or rispcridonc. Carbarnazepinc combined with lithium had significanlly fewer neurological side effects than haloperidol plus lithium wilh equivalent therapeutic reslllls. Mono· therapy with either lithium or carb
Yale University School of Medicine. Dcpanmenl of Psychiatry. New Haven, CT 06519
Tell r-=rr:ent of ehildbcari!lS women will de':elop depression aftcr delivery. To date. there has been no published report of a double-blind. placebo-controlled study of antidepress:mt treatment in poslpartum depression. The purpose of thi" ongoing ~tudy is further our knowledge of the phenomenology, neurobiology and pharmacological trealment of mojor dcpression which has ils onset within silt months of childbirth. Subjects were outpatients of the Yale Postpartum Mood Disorders Clinic and mct DSM·IV criteria for major depression with onset of symptoms within the first 6 months or childbirth. After a 1-2 week placebo lcud-in, women were randomiledlo serlrnline (Zoloft) or plm:ebo for 6 week~. The main outcome measures for antidepressant response were the Hamilton RatIng Scale for Depression and the Clinical Global Impression scale. Thus far. six of fourleen women who have been screened have entered the sludy. The menn age:!: S.D. of those enrolled is 29.1 ± 4.6 years. One woman, wbo was randomized to sertrnline, was a "responder," while two olhers are slilt in the double-blind phase. Of lhe two women
409. DOUBLE-BLIND COMPARISON OF SEXUAL DYSFUNCTION ON IMIPRAMINE AND PAROXETINE A. Ontiveros, M. Valdes. & A. Costflla Department of Psychiatry. University Hospitnl U.A.N.L .• Monterrcj, N.L.• C.P. 64461 Mcltieo Scltual dysfunction; (SDys) frequenlly accompany major depression. but can also be collaternl effects of ontidepressanls. We compared the incidence of SDys In patienls under double-blind treatment with Imipm-
Abstracts
mOL PSYCHIATRY 1996;39:500-666
nonnalized following improvement In depressive symptoms. The results of this study provide strong support for the role of the sel"Olonergic syslem in the pathopbysiology of seasonal affective disorder and in the mechanism of :lclion of light ther.lpy.
Who dccompensatcd while on placebo. bOlh have subsequently "respond. cd" to open-label scrtraline. The sixth palient, who dropped out. was nl80 on active sertraline nnd WilS improved at her last appointment. Preliminary findings from this ongoing study indicate Ihal scnraline may be efficacious in the treatment of poslpartum depression. Detailed results including comorbid diagnoses. severity of depression and personal and family psychialric history will be presented.
406. BROFAROMINE IN SOCIAL PHOBIARECENT FINDINGS FROM A US TRIAL R.J. Katz, M. Lou, & the Brofaromine Investigator's Group* eNS. Medical and Cliniclll Developmcnt. elBA Pharmnceuticuls. Summit. NJ 07901
Brofaromine is il selective and reversible MAO·A inhibitor with S·HT uptake inhibitory properties. Brofaromine Protocol 04 was a ramJomizcd. double-blind parallel-placebo trial. Patients with DSM m·R diagnosed social phobin were studied for 12 wcc:ks at doses of 100-150 mg/d. One hundred six patienls were randomized and 102 supplied efficacy data. Mean LSPS scores on entry for broraromine nod placebo were approximately 80. Visit T difference scores for drug and placebo were 62.6 and 10.7 respectively (p<.029). Physician Global ratings tcnded 10 covary with social phobia scores. These findings are consistent with IWO previous European trials (Van Vlir.t, Fahlcn) indicating significant effects of Brofarominc in social phobia. •J. Ballengt:f, P. Bohn. B. Diamond. A. Feiger.l. Greist, R. Landbloom. T. Mellman, D. Muniack. P. Ninan, W. Pettie, E. Reiman, & P. Tucker
407. CONTROLLED STUDY OF ANTIDEPRESSANT TREATMENT OF POSTPARTUM DEPRESSION C.N. Epperson, C,J. McDougle, D. Ward-O'Brien, & L.H. Price
408. SEQUENTIAL STUDIES OF THE TREATMENT OF MANIA 1.G. Small, M.H. Klapper, V. Milstein, J,D. Marhenke, & I.F. Small Department of Psychiatry, Indiana UniversilY School of Medicine. Indianapolis. IN; Larue D. Carter Memorial Hospital. 1315 W. 10th SI., Indianapolis. IN 46202 Between 1980 and 1995 a. series of therapeutic trials involving 130 bipolar I manic palients was conducled ut a single facility. Ench lrial consisted of comparisons of lithium with various other therapeulic lIgents alone or in combination including ECf. carbamazepinc. haloperidol and rispcridone. AU studies involved standard diagnostic interviews and similar research designs with two weeks of drug washOUI followed by 8 weeks of randomized or arbitrarily a.~signed treatment with weekly standard ratings of psychopalhology. Data from the above trials were pooled 10 assess comparative efficacy a.nd side effects. No clinically important baseline differences were found despite lhe 15 yetlt time span. Palienls wC'r~ no~ o-~crly "difficult to Ireat" or treatment resistant and most were dischnrgedto the community. Outcome after eight weeks was best in the ECT patienls followed by those assigned 10 lithium combined with tow do~s of standard ncuroleptics or rispcridonc. Carbarnazepinc combined with lithium had significanlly fewer neurological side effects than haloperidol plus lithium wilh equivalent therapeutic reslllls. Mono· therapy with either lithium or carb
Yale University School of Medicine. Dcpanmenl of Psychiatry. New Haven, CT 06519
Tell r-=rr:ent of ehildbcari!lS women will de':elop depression aftcr delivery. To date. there has been no published report of a double-blind. placebo-controlled study of antidepress:mt treatment in poslpartum depression. The purpose of thi" ongoing ~tudy is further our knowledge of the phenomenology, neurobiology and pharmacological trealment of mojor dcpression which has ils onset within silt months of childbirth. Subjects were outpatients of the Yale Postpartum Mood Disorders Clinic and mct DSM·IV criteria for major depression with onset of symptoms within the first 6 months or childbirth. After a 1-2 week placebo lcud-in, women were randomiledlo serlrnline (Zoloft) or plm:ebo for 6 week~. The main outcome measures for antidepressant response were the Hamilton RatIng Scale for Depression and the Clinical Global Impression scale. Thus far. six of fourleen women who have been screened have entered the sludy. The menn age:!: S.D. of those enrolled is 29.1 ± 4.6 years. One woman, wbo was randomized to sertrnline, was a "responder," while two olhers are slilt in the double-blind phase. Of lhe two women
409. DOUBLE-BLIND COMPARISON OF SEXUAL DYSFUNCTION ON IMIPRAMINE AND PAROXETINE A. Ontiveros, M. Valdes. & A. Costflla Department of Psychiatry. University Hospitnl U.A.N.L .• Monterrcj, N.L.• C.P. 64461 Mcltieo Scltual dysfunction; (SDys) frequenlly accompany major depression. but can also be collaternl effects of ontidepressanls. We compared the incidence of SDys In patienls under double-blind treatment with Imipm-