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Effect of adjunctive brexpiprazole on functioning in three exploratory, open-label studies in major depressive disorder
S406
P.2.b. Mood disorders and treatment − Affective disorders (clinical)
[2] Dudek, D., Siwek, M., Zieli´nska, D., Jaeschke, R., Rybakowski, J., 2013. Diagnostic conversions from major depressive disorder into bipolar disorder in an outpatient setting: results of a retrospective chart review. J Affect Disord. Jan 10;144(1−2):112−5. [3] Coryell et al. 1995. Long-term stability of polarity disinctions in the affective disorders. Am J Psychiatry; 152:385–390. [4] Oquendo, M.A., Barrera, A., Ellis, S.P., Li, S., Burke, A.K., Grunebaum, M., Endicott, J., Mann, J.J., 2004. Instability of symptoms in recurrent major depression: a prospective study. Am J Psychiatry. Feb; 161(2): 255−61. [5] Paykel, E.S., Prusoff, B.A., Tanner, J., 1976. Temporal stability of symptom patterns in depression. Br J Psychiatry. Apr; 128: 369−74.
P.2.b.046 Effect of adjunctive brexpiprazole on functioning in three exploratory, open-label studies in major depressive disorder R. Baker1 ° , Y. Matsushima2 , K. Tsuneyoshi3 , C. Weiss4 , A. Skuban5 , E. Weiller6 1 Otsuka Pharmaceutical Development & Commercialization- Inc., CNS Global Medical Affairs, Princeton, USA; 2 Otsuka Pharmaceutical Co. Ltd, Office of BiostatisticsHeadquarters of Clinical Development, Tokyo, Japan; 3 Otsuka Pharmaceutical Development & Commercialization Inc., Office of Biostatistics- Department of Biometrics, Tokyo, Japan; 4 Otsuka Pharmaceutical Development and Commercialization- Inc., Global Medical Affairs, Princeton, USA; 5 Otsuka Pharmaceutical Development and Commercialization- Inc., Global Clinical Development, Princeton, USA; 6 H. Lundbeck A/S, Medical Affairs, Valby, Denmark Background: Functional and cognitive impairment is common in major depressive disorder (MDD). Brexpiprazole is a serotonindopamine activity modulator that is a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors, all at similar potency. Brexpiprazole was approved in the US in 2015 for use as an adjunctive therapy to antidepressants for the treatment of MDD. We evaluated the effect of adjunctive brexpiprazole on the patient functioning domains of work/school, social life, and family/home responsibilities using the Sheehan Disability Scale (SDS) in three open-label exploratory studies. We also evaluated cognitive and physical function using the Cognitive and Physical Functioning Questionnaire (CPFQ). Methods: Three exploratory open-label studies were conducted in patients with MDD and inadequate response to antidepressant therapy (ADT): (1) inadequate response to adjunctive treatment [NCT02012218], (2) anxiety symptoms [NCT02013531], and (3) young patients at work or school [NCT02013609]. Patients received ADT+brexpiprazole 1−3 mg/day (target dose: 2 mg/day). The SDS is a visual analogue scale (self-report tool) using spatiovisual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains work/school, social life, and family/home responsibilities (0 = not at all; 10 = extremely). Scores 5 are associated with significant functional impairment. The CPFQ is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue, consisting of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning); total score ˚ range: 7−42. The Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-rated scale was used for assessment of depressive symptoms. Adjusted mean on change from baseline to endpoint are presented for all 3 scales. Results: SDS mean scores at baseline ranged from 6.3 (study 1) to 6.5 (studies 2 and 3). Improvements were observed in SDS
mean scores from baseline to Week 6/12 in patients treated with ADT+ brexpiprazole: changes from baseline to week 6: −3.1 (study 1); −3.6 (study 2); and week 12: −3.7 (Study 3). CPFQ total scores at baseline ranged from 26.1 (study 3) to 29.3 (study 1). Improvements were observed in CPFQ total scores from baseline to Week 6/12 in patients treated with ADT+ brexpiprazole: changes from baseline to week 6: −9.2 (study 1); −9.9 (study 2); and week 12: −8.1 (Study 3). MADRS total scores at baseline ranged from 28.3 (study 3) to 30.3 (study 2). Improvements were observed in MADRS total score from baseline to Week 6/12 in patients treated with ADT+ brexpiprazole: changes from baseline to week 6: −17.3 (study 1); −19.6 (study 2); and week 12 (study 3): −18.1. Conclusion: Baseline SDS and CPFQ mean scores indicated high levels of functional impairment and cognitive dysfunction in all 3 studies. Meaningful decreases from baseline to study endpoint indicated improvements in all 3 domains of the SDS: work/school, social life, and family/home responsibilities, as well as improvement in patient-rated cognitive function and increased energy/alertness after adjunctive treatment with brexpiprazole. The functional improvements were paralleled by similarly meaningful improvements in clinician-rated depressive symptoms. Disclosure statement: Full-time employee of Otsuka Pharmaceutical Development and Commercialization, Inc
P.2.b.047 Deliberate self-harm and psychiatric disorders as predictors of attempted suicide in prison inmates A. Murru1 ° , N. Verdolini1,2 , L. Attademo3 , M.A. Furio1,4 , I. Pacchiarotti1 , C.D.M. Bonnin1 , M. Piselli5 , A. Tortorella2 , E. Vieta1 1 Bipolar disorders program Institute of neuroscience. Hospital cl´ınic, Department of Psychiatry, Barcelona, Spain; 2 Division of Psychiatry- Clinical Psychology and Rehabilitation, Department of Medicine- Santa Maria della Misericordia Hospital- University of Perugia, Perugia, Italy; 3 USC Psichiatria 1, Department of Mental Health- ASST Papa Giovanni XXIII, Bergamo, Italy; 4 UOC di Psichiatria Universitaria, Dipartimento di Medicina di base- Neuroscienze e Organi di senso- University ‘Aldo Moro’, Bari, Italy; 5 Servizio Psichiatrico Diagnosi e Cura Ospedale S. Giovanni Battista, Functional Area of PsychiatryUniversity of Perugia- AUSL Umbria 2, Foligno, Italy Introduction: Suicide rates among prisoners are higher compared to the general population [1]. Being male, married [2] and other socio-demographic characteristics, as well as psychiatric conditions, are related with a higher risk of attempted suicide. The possible contributions of specific psychiatric disorders and related clinical features in attempted suicide in prison inmates have not been extensively studied. Aim: To investigates correlates of lifetime attempted suicide in prison inmates. Methods: Between October 2010 and September 2011, male prisoners aged 18 or more serving a sentence at the Spoleto Prison (Umbria-Italy) were assessed with a psychiatric evaluation (SCID-I and SCID-II). Drug and alcohol use were tested with the ASI-X scale, and other medical, sociodemographic, clinical variables were systematically collected. Self-injurious behaviors without intention to die were assessed with the DSHI inventory. To compare inmates with or without lifetime attempted suicide, chi-square tests or independent-samples t-tests were used. An
P.2.b. Mood disorders and treatment − Affective disorders (clinical)
[2] Dudek, D., Siwek, M., Zieli´nska, D., Jaeschke, R., Rybakowski, J., 2013. Diagnostic conversions from major depressive disorder into bipolar disorder in an outpatient setting: results of a retrospective chart review. J Affect Disord. Jan 10;144(1−2):112−5. [3] Coryell et al. 1995. Long-term stability of polarity disinctions in the affective disorders. Am J Psychiatry; 152:385–390. [4] Oquendo, M.A., Barrera, A., Ellis, S.P., Li, S., Burke, A.K., Grunebaum, M., Endicott, J., Mann, J.J., 2004. Instability of symptoms in recurrent major depression: a prospective study. Am J Psychiatry. Feb; 161(2): 255−61. [5] Paykel, E.S., Prusoff, B.A., Tanner, J., 1976. Temporal stability of symptom patterns in depression. Br J Psychiatry. Apr; 128: 369−74.
P.2.b.046 Effect of adjunctive brexpiprazole on functioning in three exploratory, open-label studies in major depressive disorder R. Baker1 ° , Y. Matsushima2 , K. Tsuneyoshi3 , C. Weiss4 , A. Skuban5 , E. Weiller6 1 Otsuka Pharmaceutical Development & Commercialization- Inc., CNS Global Medical Affairs, Princeton, USA; 2 Otsuka Pharmaceutical Co. Ltd, Office of BiostatisticsHeadquarters of Clinical Development, Tokyo, Japan; 3 Otsuka Pharmaceutical Development & Commercialization Inc., Office of Biostatistics- Department of Biometrics, Tokyo, Japan; 4 Otsuka Pharmaceutical Development and Commercialization- Inc., Global Medical Affairs, Princeton, USA; 5 Otsuka Pharmaceutical Development and Commercialization- Inc., Global Clinical Development, Princeton, USA; 6 H. Lundbeck A/S, Medical Affairs, Valby, Denmark Background: Functional and cognitive impairment is common in major depressive disorder (MDD). Brexpiprazole is a serotonindopamine activity modulator that is a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors, all at similar potency. Brexpiprazole was approved in the US in 2015 for use as an adjunctive therapy to antidepressants for the treatment of MDD. We evaluated the effect of adjunctive brexpiprazole on the patient functioning domains of work/school, social life, and family/home responsibilities using the Sheehan Disability Scale (SDS) in three open-label exploratory studies. We also evaluated cognitive and physical function using the Cognitive and Physical Functioning Questionnaire (CPFQ). Methods: Three exploratory open-label studies were conducted in patients with MDD and inadequate response to antidepressant therapy (ADT): (1) inadequate response to adjunctive treatment [NCT02012218], (2) anxiety symptoms [NCT02013531], and (3) young patients at work or school [NCT02013609]. Patients received ADT+brexpiprazole 1−3 mg/day (target dose: 2 mg/day). The SDS is a visual analogue scale (self-report tool) using spatiovisual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains work/school, social life, and family/home responsibilities (0 = not at all; 10 = extremely). Scores 5 are associated with significant functional impairment. The CPFQ is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue, consisting of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning); total score ˚ range: 7−42. The Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-rated scale was used for assessment of depressive symptoms. Adjusted mean on change from baseline to endpoint are presented for all 3 scales. Results: SDS mean scores at baseline ranged from 6.3 (study 1) to 6.5 (studies 2 and 3). Improvements were observed in SDS
mean scores from baseline to Week 6/12 in patients treated with ADT+ brexpiprazole: changes from baseline to week 6: −3.1 (study 1); −3.6 (study 2); and week 12: −3.7 (Study 3). CPFQ total scores at baseline ranged from 26.1 (study 3) to 29.3 (study 1). Improvements were observed in CPFQ total scores from baseline to Week 6/12 in patients treated with ADT+ brexpiprazole: changes from baseline to week 6: −9.2 (study 1); −9.9 (study 2); and week 12: −8.1 (Study 3). MADRS total scores at baseline ranged from 28.3 (study 3) to 30.3 (study 2). Improvements were observed in MADRS total score from baseline to Week 6/12 in patients treated with ADT+ brexpiprazole: changes from baseline to week 6: −17.3 (study 1); −19.6 (study 2); and week 12 (study 3): −18.1. Conclusion: Baseline SDS and CPFQ mean scores indicated high levels of functional impairment and cognitive dysfunction in all 3 studies. Meaningful decreases from baseline to study endpoint indicated improvements in all 3 domains of the SDS: work/school, social life, and family/home responsibilities, as well as improvement in patient-rated cognitive function and increased energy/alertness after adjunctive treatment with brexpiprazole. The functional improvements were paralleled by similarly meaningful improvements in clinician-rated depressive symptoms. Disclosure statement: Full-time employee of Otsuka Pharmaceutical Development and Commercialization, Inc
P.2.b.047 Deliberate self-harm and psychiatric disorders as predictors of attempted suicide in prison inmates A. Murru1 ° , N. Verdolini1,2 , L. Attademo3 , M.A. Furio1,4 , I. Pacchiarotti1 , C.D.M. Bonnin1 , M. Piselli5 , A. Tortorella2 , E. Vieta1 1 Bipolar disorders program Institute of neuroscience. Hospital cl´ınic, Department of Psychiatry, Barcelona, Spain; 2 Division of Psychiatry- Clinical Psychology and Rehabilitation, Department of Medicine- Santa Maria della Misericordia Hospital- University of Perugia, Perugia, Italy; 3 USC Psichiatria 1, Department of Mental Health- ASST Papa Giovanni XXIII, Bergamo, Italy; 4 UOC di Psichiatria Universitaria, Dipartimento di Medicina di base- Neuroscienze e Organi di senso- University ‘Aldo Moro’, Bari, Italy; 5 Servizio Psichiatrico Diagnosi e Cura Ospedale S. Giovanni Battista, Functional Area of PsychiatryUniversity of Perugia- AUSL Umbria 2, Foligno, Italy Introduction: Suicide rates among prisoners are higher compared to the general population [1]. Being male, married [2] and other socio-demographic characteristics, as well as psychiatric conditions, are related with a higher risk of attempted suicide. The possible contributions of specific psychiatric disorders and related clinical features in attempted suicide in prison inmates have not been extensively studied. Aim: To investigates correlates of lifetime attempted suicide in prison inmates. Methods: Between October 2010 and September 2011, male prisoners aged 18 or more serving a sentence at the Spoleto Prison (Umbria-Italy) were assessed with a psychiatric evaluation (SCID-I and SCID-II). Drug and alcohol use were tested with the ASI-X scale, and other medical, sociodemographic, clinical variables were systematically collected. Self-injurious behaviors without intention to die were assessed with the DSHI inventory. To compare inmates with or without lifetime attempted suicide, chi-square tests or independent-samples t-tests were used. An