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ITALIAN ISDB STUDY ON DEPRESSION - ISD
A research and training/educational project
M.Font, M.Andretta, C.Anecchino, G.Danti, F.Del
Zotti, K.Di Biagio, R.Joppi, L.Mezzalira,
M.Romero, C.Roni, E.Sasso, G.Tognoni for
the Italian ISD Working Group
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AIFA research projects are funded via a tax

• From 2005 onwards the Italian Agency on Medicines
  (AIFA), each year
• Establishes a dedicated funding stream to
  support crucial patient care-focused research (5
  of drug companies promotional expenses)
• Allocates funds to projects in three research
  areas (rare diseases head to head comparisons
  among NHS reimbursed treatments epidemiological
  studies) based on an assessment of their priority
• Selects the projects to be funded (through a
  national/ international board)

Up to now 105 projects have been funded ( 65
Mil), ISD is one of these
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The clinical problem

• The diagnostic approach of GPs to depressive
  symptoms deeply differs from what occurs in
  psychiatric practice
• Data to quantify the epidemiological magnitude
  of depression in Primary Care and to clearly
  define GPs therapeutic approach are very little.
• Therapeutic approach
• ? II generation ADs proposed as magic
  bullets, although there is a substantial
  overlapping between first and second generation
  antidepressants
• ? Increasingly promotion of ADs for prescription
  among GPs for a wide range of depressive symptoms
• ? II generation ADs do not differ from placebo
  and from non-pharmacological approaches in the
  greatest majority of cases

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Study Aims
To investigate the epidemiological profile of
patients who see their GP for depressive symptoms
and to document the spectrum, the quality, the
outcomes of treatment strategies
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Study Design Prospective epidemiological
surveillance (12 months follow-up)
Patients with problems which the GP perceives as
amenable
Assessment and qualification of the patients
diagnosis
Additional Assessment/ Follow-up
Confirmed
Probable
Uncertain
Adoption of care strategy
Not pharmacological
Symptomatic drugs
Specific drugs
certain
uncertain
Randomization
Drug
Not Drug
3 months Follow-up
Additional contacts
6 months Follow-up
Additional contacts
End of the study 12 months
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Study Participation
3.000 5.000 Patients and up to 500 Italian GPs
are expected to be part of the study, to provide
a population who could be considered
representative of different settings of Primary
Care as well as of cultural-professional
background
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TIMING OF ISD ACTIVITIES

• 2006-2007
• Research Network organization General
  Practitioners Pharmaceutical Departments of the
  Local Health Units (LHU)
• Pilot phase Protocol and Case Report Form
  definition (40 GPs involved)
• Study approval by the Ethical Committee (EC) of
  the Coordinating Centre
• 2008 (January)
• Beginning of the recruitment (about 40 GPs)
• Today (November 2008)

www.isd-gp.it
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Expected results

• ISD will
• give the first large-scale epidemiological
  profile of depression in Primary Care
• evaluate the study population exposed to
  different treatments against socio-cultural
  indicators
• show existing (if any) differences in clinical
  outcomes of different treatment approaches (after
  12 months follow-up)

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Thank you for your attention