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P0061 - Clinical outcome and tolerability of Duloxetine in the treatment of major depressive disorder: A 12-week study with plasma levels

Published online by Cambridge University Press:  16 April 2020

L.S. Volonteri ,
G. Cerveri ,
A. Colasanti ,
I. De Gaspari ,
M.C. Mauri  and
C. Mencacci
L.S. Volonteri
Affiliation:
Department of Clinical Psychiatry, Ospedale Fatebenefratelli E Oftalmico, Milan, Italy
G. Cerveri
Affiliation:
Department of Clinical Psychiatry, Ospedale Fatebenefratelli E Oftalmico, Milan, Italy
A. Colasanti
Affiliation:
Clinical Neuropsychopharmacology Unit, Department of Clinical Psychiatry, University of Milan, Foundation IRCSS Ospedale Maggiore, Milan, Italy
I. De Gaspari
Affiliation:
Clinical Neuropsychopharmacology Unit, Department of Clinical Psychiatry, University of Milan, Foundation IRCSS Ospedale Maggiore, Milan, Italy
M.C. Mauri
Affiliation:
Clinical Neuropsychopharmacology Unit, Department of Clinical Psychiatry, University of Milan, Foundation IRCSS Ospedale Maggiore, Milan, Italy
C. Mencacci
Affiliation:
Department of Clinical Psychiatry, Ospedale Fatebenefratelli E Oftalmico, Milan, Italy

Abstract

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Background and Aims:

Duloxetine (DLX) is approved for treatment of Major Depressive Disorder (MDD).

Aims of this study were to assess the clinical outcome of DLX in the treatment of MDD, with efficacy measures based on clinician and patient assessment, and to evaluate the predicitve value of DLX plasma levels on clinical response.

Methods:

45 out-patients affected by MDD were included in the study and prescribed 30-120 mg/day of DLX for 12 weeks.

Patients were evaluated at T0, after 2 (T1), 4 (T2), and 12 weeks (T3), by using HAMD21, HAMA, CGI-S, and the self-rating scales BDI and VAS. Plasma samples were collected at T2.

Results:

Responders (50% reduction in HAMD21) were 60% and remitters (HAMD21 ≤7) were 56%. HAMD21 showed a significant improvement at T1, T2, T3 vs T0. HAMA and CGI-S showed a significant improvement at T2, T3 vs T0.

15 (33%) patients discontinued the treatment.

Blood pressure, heart rate, and body weight did not show relevant changes.

DLX plasma levels ranged from 5 ng/ml to 135 ng/ml (mean 53.56 ± 39.45 SD). The incidence of side effects irritability and anxiety was found to be significantly correlated with the highest DLX level/dose (mean 1.6 ng/ml/mg ± 0.29 SD) (p=0.02).

We observed a curvilinear relationship between HAMD21 percentage of amelioration at T2 and DLX plasma levels/dose (mg/kg) (y=22.74+0.78x-0.0038x2, R2=0.134; p=0.23).

Conclusion:

Good medium-term clinical response, but plasma levels showed an increased of adverse events at higher values, reducing the advantages of dose escalation.

Type
Poster Session II: Antidepressants
Information
European Psychiatry , Volume 23 , Issue S2: 16th AEP Congress - Abstract book - 16th AEP Congress , April 2008 , pp. S210
Copyright
Copyright © European Psychiatric Association 2008
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