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Unformatted text preview: n our protocol for this meta-analysis
we defined the criteria for selecting trials,
before we accessed the trials database: (a)
identical or very similar clinical inclusion
criteria for patients (major depression as
defined by DSM±III (American Psychiatric
Association, 1980); (b) use of the Hamilton
Depression Rating Scale (HDRS±17; Hamilton, 1967; and the first 17 items from
trials that used more than 17); and (c) a
double-blind follow-up phase of at least
six weeks. For the non-USA trials, we analysed only trials of fluoxetine v. TCAs since
the three non-USA placebo-controlled trials
(116 patients) in the database did not satisfy our inclusion criteria or included very
few patients. The same inclusion criteria
were used for non-USA trials, except that
trials with a five-week, double-blind follow-up period were also included since
their exclusion would have led to only a
handful of trials with a small number of
patients being included. The database
contained only one USA trial with a fiveweek double-blind follow-up period, but
this was not included.
Trials without a control treatment (e.g.
dose-ranging trials) and those with a control treatment other than placebo or a
TCA were excluded. In addition, trials in
which all control patients received fixed
doses 475 mg/day of a TCA were eliminated, as were those in which treated
patients received less than 10 mg/day of
fluoxetine. Within a trial, all patients were
pooled according to the treatment received,
irrespective of the dose received, this being
equivalent to comparing a single fluoxetinetreated group with a single TCA-treated
group and a single placebo-treated group.
The first evidence-based diagnostic
system in psychiatry is the DSM±III. Newgeneration antidepressants are indicated
for major depression as defined using this
diagnostic system in most countries, and
this is the reason we decided to use DSM±
III major depression as the only diagnostic
The database contained information for
69 trials, including 6633 patients; of these,
21 trials were USA trials and 48 had been
performed elsewhere (non-USA tri...
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This note was uploaded on 01/16/2013 for the course BMS 620 taught by Professor Panavalil during the Summer '12 term at Barry Univesity.
- Summer '12