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Introduction
Studies with fluoxetine (Connor et al., 1999), sertraline
(Davidson et al., 2001a) and paroxetine (Tucker et al.,
2001) have shown that symptom remission can be
attained in the treatment of post-traumatic stress
disorder (PTSD). In the case of sertraline, although data
indicate that prolonged open-label treatment can dissolve
most symptoms, actual rates of remission have not been
published.
Definitions of remission in the PTSD literature have
largely been chosen on an ad hoc basis. For example, in
the fluoxetine study (Connor et al., 1999), remission
was defined as a Composite High Endstate Function
score, based upon asymptomatic status on a self-rating
the Davidson Trauma Scale (DTS) (Davidson, 1996)
and observer rating the Treatment Outcome PTSD
Scale (Davidson et al., 1997) of PTSD, and a self-rating
of disability. In this case, the self-rated DTS score
was required to be no higher than 17. In a study of
paroxetine (Tucker et al., 2001), remission was set at a
total Clinician Administered PTSD Scale (CAPS) (Blake
et al., 1995) score of less than 20. Although these scores
are intuitively reasonable, they have not been tested in
comparison with a more objective index of clinical
remission. One such index could be a separate clinical
global rating which indicates at least: (i) very much
improvement and (ii) symptoms no worse than of mild
intensity.
c 2004 Lippincott Williams & Wilkins
0268-1315 !
Psychopharmacol 19:8587
Wilkins.
!
c
Methods
Subjects were obtained from two double-blind, placebocontrolled, 12-week trials of sertraline and PTSD (Brady
et al., 2000; Davidson et al., 2001b). All subjects were at
least 18 years of age, fulfilled DSM-III-R (American
Psychiatric Association, 1987) criteria for PTSD, along
with a CAPS-I score of at least 50. Each study had been
approved by a local institutional Institutional Review
Board, and all subjects provided their written informed
consent. The material presented in the results is based
upon the final visit DTS, CAPS and CGI-I and CGISeverity (CGI-S) scores.
DOI: 10.1097/01.yic.0000113107.67404.cd
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86
Results
Three hundred and eighty-four subjects were available
for analysis, of whom 290 (75.5%) were female, and 323
(84.2%) were white. The mean (SD) age of subjects was
38.4 (10.4) years.
Rates of remission with sertraline and placebo
Table 1
DTS cut-off
score
16
17
18
19
20
17
18
19
20
21
30%
CGI-I = 1and
CGI-S = 1,2,3
20%
13.9
13.9
10%
SERT PBO
SERT PBO
0.952
0.952
0.939
0.936
0.936
0.747
0.803
0.803
0.817
0.873
0.943
0.955
0.955
0.958
0.970
3.755
4.828
4.764
5.113
7.385
0.914
0.925
0.919
0.914
0.925
Sensitivity
Specificity
PPV
PLR
Efficiency
0.974
0.964
0.964
0.955
0.942
0.632
0.697
0.737
0.750
0.776
0.915
0.928
0.937
0.939
0.945
2.644
3.186
3.664
3.818
4.209
0.906
0.911
0.919
0.914
0.909
23.0
14.9
Efficiency
Table 3
26.2
24.7
PLR
CAPS < 20
PPV
Table 2
DTS <18
Specificity
Fig. 1
Sensitivity
SERT PBO
Sensitivity
DTS cut-off score
11
0.961
14
0.945
17
0.915
20
0.896
CAPS cut-off score
16
0.971
18
0.948
19
0.941
20
0.928
Specificity
PPV
PLR
Efficiency
0.442
0.507
0.597
0.649
0.873
0.884
0.901
0.911
1.721
1.914
2.274
2.555
0.857
0.857
0.852
0.846
0.520
0.623
0.636
0.638
0.890
0.909
0.912
0.911
2.020
2.517
2.589
2.553
0.880
0.883
0.880
0.870
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Discussion
Sertraline lead to remission significantly more often than
placebo on all three PTSD outcomes, making it the only
drug so far known to produce remission on several
measures in a large multicentre PTSD sample. The
difference in remission rates of 912% between drug
and placebo is similar to the 12.9% difference reported
for paroxetine versus placebo on the CAPS (Tucker
et al., 2001).
Our results also established that the initially adopted
DTS and CAPS thresholds to define remission are
clinically valid with reference to a CGI-based definition
of remission. Indeed, the respective scores fall very close
to the cut-offs that were shown to have the highest
diagnostic accuracy in the test threshold analyses. It
would appear as though either scale (CAPS or DTS) can
serve as a clinically valid reflection of symptom remission,
using the originally proposed cut-offs, although a slight
adjustment of the threshold might lead to marginally
higher accuracy relative to a clinical global rating.
Normative general population scores are available for the
DTS (Davidson et al., 1996; Davidson et al., 2002), and
they indicate a mean score of 11.0 for all traumatized
individuals. This turns out to correspond closely to the
optimum range of scores (Londborg et al., 2001; Tucker
et al., 2001; Weathers et al., 2001) found to match the
CGI-based definition of remission. The overall rates of
remission on sertraline and placebo were practically
identical across the three definitions, ranging from
23.126.3% for sertraline, and 13.914.9% for placebo. It
is noted that longer-term treatment can perhaps increase
the numbers of subjects who achieve clinical remission
from PTSD (Londborg et al., 2001). Indeed, when the
data of Londborg et al. (2001) were assessed for patients
who were treated with only sertraline for 9 months,
remission rates according to the CAPS increased from
31% after 14 weeks to 63.5% at endpoint. This would
suggest a potential doubling of the remission rate if
treatment persists beyond 3 months for up to 9 months.
Acknowledgements
Funding was provided to the author by Pfizer, Inc, for
whom he has serves as an investigator, consultant and
speaker.
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