WHAT ARE THE BEST WAYS OF DEFINING REMISSION IN ANXIETY DISORDERS - PowerPoint PPT Presentation

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WHAT ARE THE BEST WAYS OF DEFINING REMISSION IN ANXIETY DISORDERS

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Panic and Agoraphobia Scale (P&A) Specifically designed to monitor treatment efficacy ... Compatible with DSM-IV or ICD-10 Panic Disorder With or Without Agoraphobia ... – PowerPoint PPT presentation

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Title: WHAT ARE THE BEST WAYS OF DEFINING REMISSION IN ANXIETY DISORDERS


1
WHAT ARE THE BEST WAYS OF DEFINING REMISSION IN
ANXIETY DISORDERS?
  • Borwin Bandelow
  • University of Göttingen, Germany
  • Dept. of Psychiatry and Psychotherapy

Dr Bandelow has been a consultant for, received
grant/research support from, and been on the
speakers/advisory board for AstraZeneca,
Bristol-Myers-Squibb, GlaxoSmithKline,
Janssen-Cilag, Lilly, Lundbeck, Pfizer, Roche,
Sanofi-Aventis, Solvay, Wyeth
2
Göttingen
  • 45 Nobel Prize Winners
  • Nuclear Fission (Otto Hahn)
  • Bell Curve (Gauss)

3
Definition of clinically meaningful change
  • More than 1.96 standard deviations under the mean
    of the ill population

Less than 1.96 standard deviations over the mean
of the healthy population
Healthy population
Ill population
Nearer to the mean of the healthy population than
to the ill population
Requires normative data!
Healthy population
Ill population
4
RELIABLE CHANGE INDEX(Jacobson Truax, 1991)
  • x1 pre-treatment score
  • x2 pre-treatment score
  • s1 pre-treatment standard deviation
  • rxx test-retest reliability of the scale

When RC 1.96 then it is probable that there was
an actual change When RC 1.96 then the
difference occured through unprecise measurement
5
Remission Response - CGI
  • Response CGI Improvement (CGI-I)
  • much improved or
  • very much improved
  • Remission CGI Severity (CGI-S)
  • not at all ill or
  • borderline mentally ill

6
2 Methods for Measuring Improvement
7
Response Conventional definition
  • 50 reduction on a standard rating scale, e.g.
  • Depression MADRAS, HAMD
  • GAD HAMA
  • Panic Disorder PA, PDSS
  • SAD LSAS

8
What is the threshold for symptomatic response
and remission?
  • Randomized controlled studies
  • Major depression (5 studies)
  • Panic disorder (1 study)
  • GAD (4 studies)
  • SAD (2 studies)
  • Comparison of effect sizes of CGI and gold
    standard scale for these disorders (MADRS, PA,
    HAM-A, and LSAS).

Bandelow, Baldwin, Dolberg, Friis Andersen,
Stein. JCP, submitted
9
Corresponding CGI-I values for mean changes ()
from baseline of the total scores of the standard
scales
10
Response
  • 50 reduction on a standard scale may be too
    conservative
  • Or Patients who are much improved on the CGI-I
    still have substantial symptomatology

11
Remission Corresponding CGI-S values for mean
total scores of the standard scales
Proposals from the literature
12
Comprehensive Definition of Remission (Ballenger
et al., 1999)
  • FOR SAD
  • LSAS 30
  • HAMA 7-10
  • Sheehan Disability 1
  • HAMD 7

13
Comprehensive Definition of Remission (Ballenger
et al. 2001)
  • For Panic Disorder
  • LSAS 30
  • HAMA 7-10
  • Sheehan Disability 1
  • HAMD 7
  • Or
  • PDSS 3
  • HAMD 7

14
Detection of Differences between Active Drug and
Placeboin Panic Disorder Trials in of all
Studies
n Number of Studies
Bandelow et al., 1995)
15
Why do we need a special panic scale?
  • Other scales, such as the HAMA, are not designed
    for DSM/ICD panic disorder
  • Measuring panic attacks is not sufficient, as in
    some patients severity is determined by
    agoraphobic avoidance, anticipatory anxiety etc.
  • Panic attack frequency is not a sensitive measure
    to separate active drug from placebo
  • One main efficacy measure needed, not a battery
    of scales

16
Panic and Agoraphobia Scale (PA)
  • Specifically designed to monitor treatment
    efficacy
  • 2 versions observer-rated, self-rated
  • 13 item scale (0-4 Likert scale)
  • 5 sub-scales
  • Compatible with DSM-IV or ICD-10 Panic Disorder
    With or Without Agoraphobia
  • Inter-rater reliability 0.78 test-retest
    0.73
  • Correlation with CGI 0.90
  • 21 translations available

www.hogrefe.de
17
PA subscales
  • 1. Panic attacks
  • Frequency
  • Severity
  • Duration
  • 2. Agoraphobia
  • Frequency
  • Number of situations
  • Importance of situations)
  • 3. Anticipatory anxiety
  • Frequency
  • Severity
  • 4. Disability
  • Family
  • Social
  • Work
  • 5. Worries about health
  • Fear of having bodily disorder
  • Fear of health damage during panic attacks

18
Treatment Effect Sizes (Rosenthalss r)
Bandelow B et al (1998) The use of the Panic and
Agoraphobia Scale in a clinical trial. Psychiatry
Res 7743-9.
19
Panic Disorder Escitalopram vs. Citalopram vs.
PlaceboBandelow Panic Agoraphobia Scale (P A)

Stahl et al., 2003
20
Panic attack frequency at week 10 (LOCF)
21
Difference from placebo at week 10 for PA
subscales (LOCF)
plt.05 plt.01 plt.001 plt.05 ESC vs CIT
22
Sertraline vs. Paroxetine PAS Total and
Subscale Scoresat Week 12 / Endpoint (Per
Protocol)
LS means reduction based on ANCOVA model at Week
12 / Endpoint
Bandelow et al., 2004. J Clin Psychiatry
65405-413
23
Escitalopram Effect Sizes in Depression and 3
Anxiety Disorders
24
Panic Scales vs Panic Freqency
25
CPMP Guidelines for Panic DisorderDraft
  • In PD not only the recording of the frequency
    and severity of panic attacks (full and limited
    attacks) should be assessed but also the severity
    of agoraphobic avoidance and anticipatory anxiety
    should be evaluated. Therefore several scales
    have been developed for measurement of specific
    symptoms according to the diagnostic criteria of
    PD, which may be more appropriate for use in
    clinical trials, e.g. the Panic Disorder Severity
    Scale (PDSS)1 and the Panic and Agoraphobia Scale
    (PAS) 2, than focussing only on frequency and
    severity of panic attacks.
  • 1Shear et al. 1997
  • 2Bandelow et al. 1995

26
PA (1995) vs. PDSS (1997)
  • PA first ever panic scale
  • PA has 13 items, PDSS has 7 items
  • All PDSS items are also in the PA
  • PA Higher number of items higher reliability
  • PA better psychometric properties
  • PA Translations into gt 20 languages

27
GADSS (Shear)
  • Worries
  • Frequency
  • Distress
  • Associated Symptoms
  • Frequency
  • Severity/Distress
  • Impairment
  • Work
  • Social Functioning

28
Conclusions
  • Defintions of response and remission should not
    be based on CGI
  • Should be based on cut-off score on comprehensive
    scale
  • Scales should not be a list of symptoms, but
    should include measures of all domains that are
    dysfunctional in a certain disorder, including
    QoL measures (e.g. PA, PDSS, GADSS, Y-BOCS)
  • Cut-off scores should be determined in empirical
    trials

29
Ortrud Schweigert after her visit to the Munch
Museum
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