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P.2.033 Quality of life of patients with schizophrenia measured by schizophrenia quality of life scale
P2. Psychotic D2 dopamine J. Psychiatry
m P2
033
receptors in 56 patients taking 153 (1996), pp. 183-190.
Quality measured
of life of patients by schizophrenia
A. Suwalska, A. Rajewski, J.K. Rybakowski. University Psychiatry, Poznan, Poland
F. Rybakowski, of Medical
with
various
neuroleptics.
schizophrenia quality of life
disorders Am.
scale
D. Lojko, A. Permoda, Sciences, Department of
Introduction: The quality of life (QoL) has recently beeu iutroduced to outcome assessment in psychiatry. Methods of evaluatiou include the disease-specific QoL iustrumeuts for psychiatric patieuts populations as well the examination of generic quality of life instruments for use in psychiatric outcome studies (Bulliuger, 1997). QoL iustrumeuts specific to schizophrenia are based ou the subjective judgemeut of patients aud include ouly relevant items, which cau chauge during treatment. Wilkiusou et al (1999, 2000) developed aud validated the 30-item Schizophrenia Quality of Life Scale (SQLS). Objectives: To assess quality of life of patients with schizophreuia using SQLS. Patients and Methods: Forty-six (30 male, 16 female, meau age 48.0116.0 years) in-patients with schizophrenia @SM IV aud ICD-10 criteria) were included. Iuteusity of symptoms of schizophrenia was measured using Positive aud Negative Syudrome Scale (PANSS). SQLS aud WHOQOL Bref questiomlaire (26 items) were used to assess the quality of life. Iuteusity of depressive symptoms was evaluated by meaus of Beck Depression Iuveutory (BDI). Results: Gender effects were observed, with male patients showing significantly worse results in SQLS EuergyiMotivatiou domaiu aud a treud toward worse Psychosocial subscale results. In comparison betweeu chrouic patients aud patients recently admitted to the hospital the latter group showed teudeucy to worse Psychosocial subscale results. Younger patients (1~40) tended to have higher results in Psychosocial subscale. Results of SQLS of patients with good aud poor iusight iuto ilhless did uot differ. Patients treated with couveutioual ueuroleptics had siguificautly higher SQLS Symptom/Side effects. Associations betweeu quality of life assessment with SQLS aud WHOQoL scores aud clinical factors were also found. All domaius of SQLS correlated with the iuteusity of depression Psychosocial domaiu of SQLS correlated with overall PANSS results, positive aud general symptoms subscales as well as psychological, physical, social relationships domaius of WHOQoL. EuergyiMotivatiou dimeusiou of SQLS was associated with negative symptoms subscale of PANSS aud all domaius of WHOQoL. Symptoms/Side effects dimeusiou of SQLS correlated with psychological aud physical domaius of WHOQoL. Conclusion: The fiudiugs point to the usefuhless of diseasespecific quality of life questiomlaires in schizophrenia aud the impact of gender aud clinical symptoms of the ilhless ou quality of life. The SQLS appeared to be a practical, useful tool in the assessment of quality of life of patients with schizophrenia. References [l]
Wilkinson G, Hesdon B, Wild D, Cookson R, Farina C, Sharma \! Fitzpatrick R, Jenkinson C. Self-report quality of life measure for people with schizophrenia: the SQLS. Brit J Psychiatry (2000), 177:42-
[2]
$lkinson G Schimphreui~ SQLS. Oxford
Wild D Jenkinson C Fitzpatrick Quality’ of Life Scald (SQLS). Outcomes 1999, pp. 5-32
R Use;
Hesdon Manual
B. The for the
and [3]
mP2
antipsychotics
s293
Bullinger M. Generic quality of life assessment in psychiatry. and limitations. Eur. Psychiatry (1997), 12:203%209
034
A novel fast-disintegrating the atypical antipsychotic
oral formulation risperidone
Potentials
of
.I. Miutzer’ , PH. Lechat2, B. Remmerie2, E. Mamlnaert2. ‘Alzheimers Research & Clinical Program, Research & Clinical Program, North Charleston, SC, L!S.A.; 2Janssen Pharmaeutica, Medical Affairs CNS, Beerse, Belgium Background: Difficulties with admiuistratiou of oral tablets in 3040% of elderly patients prevent them from receiving their prescribed medication, resulting in high non-compliance aud iueffective therapy. A fast-disiutegratiug oral formulation of the atypical autipsychotic risperidoue was developed, that dissolves withiu seconds ou the tongue unlike the usual oral risperidoue tablets. Objective: Comparisiou of pharmacokiuetic properties of fastdisiutegratiug oral formulation aud oral tablets of risperidoue. Methods: Two, Phase I, open-label, single-dose, randomized, two-way crossover trials in young healthy volunteers assessed bioequivaleuce of the two fonnulatious. In the first, lmg of risperidoue (given as 2xO.5mg oral tablets) was compared to its 2x 0.5mg fast disiutegratiug oral fonnulatiou (N=43). A second trial compared the 2mg fonnulatious (N=38). Phannacokiuetic parameters included maximal plasma couceutratiou (C&,), time to reach the maximal plasma couceutratiou (t,,&, plasma elimiuatiou half-life (tt/z) aud area uuder the curve (AUCs). Relative bioequivaleuce betweeu the two fonnulatious (F,t: rauge 80%125%) was tested using 90% Co&deuce Intervals of C&,, aud AUCs log-trausfonned ratios. Results: The plasma couceutratiou-time profiles of the active moiety (the sum of risperidoue aud it’ s pharmacologically equipoteut metabolite 9-hydroxy-risperidoue) were similar for both fonnulatious at each dose. Maximum plasma couceutratious were comparable betweeu the 2xO.5mg doses of both fonnulatioiis (C&,: 12.2813.96 aud 13.2313.86 ugiml, respectively) aud betweeu the 2 mg fonnulatious (C&,:23.216.50 aud 25.317.84 ugiml, respectively). AUCs , &, aud tt/z were similar for both at each investigated dosages. F,t values for both fonnulatious were withiu the bioequivaleuce rauge for C&, [2xO.5mg: 90.1% (84.1196.5); 2mg: 92.1% (87.5596.9)] aud AUCs [2x0.5 mg: 97.2 (91.22103.6); 2mg: 98.0% (94.22101.9)]. Adverse eve&, if auy were mild aud were similar betweeu the two fonnulatious. Discussion: Fast-disintegrating oral fonnulatiou of risperidoue is bioequivaleut with its oral tablets in healthy young volunteers. While bioequivaleuce is established in healthy adults, couclusious include children aud elderly. This fast-disiutegratiug oral fonnulatiou may be particularly beneficial in patients who evade or have difficulties swallowing, thus improving adhereuce aud compliance with therapy. Conclusion: Oral fast-disiutegratiug risperidoue is bioequivaleut with its oral tablet fonnulatiou, aud may present a couveuieut aud patient-friendly alternative.
m P2
033
receptors in 56 patients taking 153 (1996), pp. 183-190.
Quality measured
of life of patients by schizophrenia
A. Suwalska, A. Rajewski, J.K. Rybakowski. University Psychiatry, Poznan, Poland
F. Rybakowski, of Medical
with
various
neuroleptics.
schizophrenia quality of life
disorders Am.
scale
D. Lojko, A. Permoda, Sciences, Department of
Introduction: The quality of life (QoL) has recently beeu iutroduced to outcome assessment in psychiatry. Methods of evaluatiou include the disease-specific QoL iustrumeuts for psychiatric patieuts populations as well the examination of generic quality of life instruments for use in psychiatric outcome studies (Bulliuger, 1997). QoL iustrumeuts specific to schizophrenia are based ou the subjective judgemeut of patients aud include ouly relevant items, which cau chauge during treatment. Wilkiusou et al (1999, 2000) developed aud validated the 30-item Schizophrenia Quality of Life Scale (SQLS). Objectives: To assess quality of life of patients with schizophreuia using SQLS. Patients and Methods: Forty-six (30 male, 16 female, meau age 48.0116.0 years) in-patients with schizophrenia @SM IV aud ICD-10 criteria) were included. Iuteusity of symptoms of schizophrenia was measured using Positive aud Negative Syudrome Scale (PANSS). SQLS aud WHOQOL Bref questiomlaire (26 items) were used to assess the quality of life. Iuteusity of depressive symptoms was evaluated by meaus of Beck Depression Iuveutory (BDI). Results: Gender effects were observed, with male patients showing significantly worse results in SQLS EuergyiMotivatiou domaiu aud a treud toward worse Psychosocial subscale results. In comparison betweeu chrouic patients aud patients recently admitted to the hospital the latter group showed teudeucy to worse Psychosocial subscale results. Younger patients (1~40) tended to have higher results in Psychosocial subscale. Results of SQLS of patients with good aud poor iusight iuto ilhless did uot differ. Patients treated with couveutioual ueuroleptics had siguificautly higher SQLS Symptom/Side effects. Associations betweeu quality of life assessment with SQLS aud WHOQoL scores aud clinical factors were also found. All domaius of SQLS correlated with the iuteusity of depression Psychosocial domaiu of SQLS correlated with overall PANSS results, positive aud general symptoms subscales as well as psychological, physical, social relationships domaius of WHOQoL. EuergyiMotivatiou dimeusiou of SQLS was associated with negative symptoms subscale of PANSS aud all domaius of WHOQoL. Symptoms/Side effects dimeusiou of SQLS correlated with psychological aud physical domaius of WHOQoL. Conclusion: The fiudiugs point to the usefuhless of diseasespecific quality of life questiomlaires in schizophrenia aud the impact of gender aud clinical symptoms of the ilhless ou quality of life. The SQLS appeared to be a practical, useful tool in the assessment of quality of life of patients with schizophrenia. References [l]
Wilkinson G, Hesdon B, Wild D, Cookson R, Farina C, Sharma \! Fitzpatrick R, Jenkinson C. Self-report quality of life measure for people with schizophrenia: the SQLS. Brit J Psychiatry (2000), 177:42-
[2]
$lkinson G Schimphreui~ SQLS. Oxford
Wild D Jenkinson C Fitzpatrick Quality’ of Life Scald (SQLS). Outcomes 1999, pp. 5-32
R Use;
Hesdon Manual
B. The for the
and [3]
mP2
antipsychotics
s293
Bullinger M. Generic quality of life assessment in psychiatry. and limitations. Eur. Psychiatry (1997), 12:203%209
034
A novel fast-disintegrating the atypical antipsychotic
oral formulation risperidone
Potentials
of
.I. Miutzer’ , PH. Lechat2, B. Remmerie2, E. Mamlnaert2. ‘Alzheimers Research & Clinical Program, Research & Clinical Program, North Charleston, SC, L!S.A.; 2Janssen Pharmaeutica, Medical Affairs CNS, Beerse, Belgium Background: Difficulties with admiuistratiou of oral tablets in 3040% of elderly patients prevent them from receiving their prescribed medication, resulting in high non-compliance aud iueffective therapy. A fast-disiutegratiug oral formulation of the atypical autipsychotic risperidoue was developed, that dissolves withiu seconds ou the tongue unlike the usual oral risperidoue tablets. Objective: Comparisiou of pharmacokiuetic properties of fastdisiutegratiug oral formulation aud oral tablets of risperidoue. Methods: Two, Phase I, open-label, single-dose, randomized, two-way crossover trials in young healthy volunteers assessed bioequivaleuce of the two fonnulatious. In the first, lmg of risperidoue (given as 2xO.5mg oral tablets) was compared to its 2x 0.5mg fast disiutegratiug oral fonnulatiou (N=43). A second trial compared the 2mg fonnulatious (N=38). Phannacokiuetic parameters included maximal plasma couceutratiou (C&,), time to reach the maximal plasma couceutratiou (t,,&, plasma elimiuatiou half-life (tt/z) aud area uuder the curve (AUCs). Relative bioequivaleuce betweeu the two fonnulatious (F,t: rauge 80%125%) was tested using 90% Co&deuce Intervals of C&,, aud AUCs log-trausfonned ratios. Results: The plasma couceutratiou-time profiles of the active moiety (the sum of risperidoue aud it’ s pharmacologically equipoteut metabolite 9-hydroxy-risperidoue) were similar for both fonnulatious at each dose. Maximum plasma couceutratious were comparable betweeu the 2xO.5mg doses of both fonnulatioiis (C&,: 12.2813.96 aud 13.2313.86 ugiml, respectively) aud betweeu the 2 mg fonnulatious (C&,:23.216.50 aud 25.317.84 ugiml, respectively). AUCs , &, aud tt/z were similar for both at each investigated dosages. F,t values for both fonnulatious were withiu the bioequivaleuce rauge for C&, [2xO.5mg: 90.1% (84.1196.5); 2mg: 92.1% (87.5596.9)] aud AUCs [2x0.5 mg: 97.2 (91.22103.6); 2mg: 98.0% (94.22101.9)]. Adverse eve&, if auy were mild aud were similar betweeu the two fonnulatious. Discussion: Fast-disintegrating oral fonnulatiou of risperidoue is bioequivaleut with its oral tablets in healthy young volunteers. While bioequivaleuce is established in healthy adults, couclusious include children aud elderly. This fast-disiutegratiug oral fonnulatiou may be particularly beneficial in patients who evade or have difficulties swallowing, thus improving adhereuce aud compliance with therapy. Conclusion: Oral fast-disiutegratiug risperidoue is bioequivaleut with its oral tablet fonnulatiou, aud may present a couveuieut aud patient-friendly alternative.