The main FDA clinical trial analysis (DNDP) looked at suicide ideation and attempts in relation to expo-sure to SSRIs although using ideation and attempts as surrogates for completed suicide is of unknown validity.
NEW STUDIES TO ADDRESS THE
RESEARCH QUESTION
The
main FDA clinical trial analysis (DNDP) looked at suicide ideation and attempts
in relation to expo-sure to SSRIs although using ideation and attempts as
surrogates for completed suicide is of unknown validity. The limitations of
available data on attempts include a low level of specificity and accuracy of
recall on self-reported rates of suicide attempts and variable and incomplete
data on ATD doses, dura-tion of drug treatment, concomitant medications and
drug switches. Furthermore, suicide attempts and self-mutilation are common in
adolescence (Safer, 1997), and they often overlap; parent reports of suicide attempts
in their offspring are underreported and suicide ideation and suicide threats
in adoles-cence are much more common than serious suicide attempts.
Consequently, for better precision it is preferable to have more definitive
evidence of docu-mented medically serious suicide attempts in relation to SSRI
treatment. Such evidence could be obtained from psychiatric-related
hospitalizations and emer-gency department (ED) visits.
Survey
data shed some light on the scope of the suicide-related medical service
utilization. The self-reported suicide attempts and those resulting in medi-cal
attention for adolescents (14–17 year olds) in the 2003 population-based high
school CDC survey was 8.5% and 2.9%, respectively. Medical attention was not
defined in the survey and presumably refers to outpatient care as well as
hospitalization or ED visits (Grunbaum et
al., 2004). By self-report then, approxi-mately 1.3 million US high school
students have made suicide attempts during the previous year.
To
obtain more precise information on suicide attempts resulting in medical
attention, ED data may be a useful approach. Specifically, administrative data
on ED visits for older youth (e.g. 10–18) could be examined. Suicide-related
reports in the ED can be sorted by age group, gender, method of attempt (e.g.
cutting, overdose) and disposition. In one study based on a multi-state
epidemiologic examination of pooled E-coded discharge data and vital statistics
(Spicer and Miller, 2000), the authors used E-codes 950–959.9 to calculate
suicide attempts from hospi-talizations or ED visits and found the rate to be
21 per 100,000 for those less than 15 years and 259 per 100,000 among 15–19
year olds. Overdoses and cutting accounted for 85%–90% of attempts.
Estimates
of the frequency of ED use for inten-tional self-injury by youths suggest that
it is relatively low. In the state of Oregon from 1988 through 1993, suicide
attempts by youths aged 10–17 as recorded in emergency rooms represented 0.3%
of all youths in that age range (MMWR, 2005). In another emer-gency room report
of 4072 adolescents (11–19 years old) presenting to an Arkansas Children’s
Hospital ED during a 1 year period in 1985, 27 (0.66%) delib-erately injured
themselves (Jay, Graham and Flowers, 2005). Thus, it is reasonable to assume
that the intentional self-injury rate varies with the region and the
completeness of identification and reporting. Another study indicates that of
the youth who came to EDs related to suicidality, at least 40% came there
because of suicidal ideation, not attempts (Stewart et al., 2001).
The
data reviewed above suggest that administra-tive claims or computerized records
data are likely to be a feasible approach to patient-level assess-ment of the
association of psychiatric-related AEs with medication exposure. Evaluating
youth who have been given ATDs as outpatients and then noting their ED and
hospital visit rate is a feasible means of directly linking the AEs to the
medication exposure. A more direct approach, the medical record audit, to
assess emergency room records might be feasible if the staff routinely recorded
in their data set prior and ongoing medication patterns of those admitted.
Unfortunately, this is not generally recorded. Using a community-based data set
across a 4-year period would allow those with a prescribed ATD (among three
subclasses) over a given time period to be identi-fied. Total ATD-treated youth
or those within selected diagnostic groups could then be evaluated for their
rate of psychiatric admission to an ED or a hospital as well as the recorded
reason for such an admis-sion (diagnostic codes and E-codes). The distinction
between this study and the Simon study is essentially that youth rather than
adults would be studied; youth and not episodes would be the unit of analysis;
and only youth with a single ATD drug class would enter each group and children
and adolescents would be separated.
The
ideal study to assess the relationship between SSRI use and suicidality in
youth requires a prospec-tive randomized cohort study design in a large usual
practice community treatment setting. Now that there are serious concerns about
the efficacy and safety of the SSRIs for youth treated for depression, the
concern about depriving a youth of an effective marketed medication in a randomized
protocol is balanced by the uncertainty of outcome. The usual ethical concern
would be overcome in this instance. In a random-ized cohort study, three groups
could be established: SSRI, other ATD or a waiting list placebo control.
Following the cohort forward for 6 months would allow information to be
collected on the effectiveness of treatment and reasons for discontinuation of
drug. Most importantly, psychiatric-related ED or outpatient visits or
hospitalizations related to hostility and acti-vation could be distinguished
from depression-related events to shed light on the major confound of many
psychotropic drug studies, namely, behavioural toxicity.
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