AD7.2.3.2 Study
Plan
AD7.2.3.2.1 Objective
Rationale
The objective of this trial was to compare the
safety and efficacy of two doses of bupropion sustained-release and placebo in
the treatment of patients with major depression.
AD7.2.3.2.2 Population
·
The
following summarizes inclusion criteria for the study:
·
Age
greater than 17 years old
·
Meeting
DSM-III-R criteria for Major Depressive Disorder, with a current Major
Depressive Episode of between four weeks and two years of duration
·
Score
of at least 20 on the 21-item Hamilton Depression Scale (HAMD) at both time of
entry and after one week of placebo washout, with a drop of not more than 20
per cent over the week of placebo washout.
·
Score
of at least 2 on the Depressed Mood item (#1) of the HAMD at both time of entry
and after one week of placebo washout.
Patients were excluded for the following:
·
Predisposition
to seizures, either by personal or family history; or by concurrent brain tumor
or seizure-threshold-lowering medications.
·
Presence
of a significant DSM-III-R Axis II diagnosis that would suggest non-responsiveness
to pharmacotherapy for depression
·
History
within one year of alcohol or substance abuse
·
Receipt
of fluoxetine or an investigational drug within four weeks of the treatment
phase, receipt of an MAOI drug or protriptyline within two weeks of the
treatment phase, or receipt of any other psychoactive drug within one week of
the treatment phase
·
History
of treatment with bupropion
·
Incapable
of spontaneous conversation or activity
·
Active
suicidality
AD7.2.3.2.3 Planned
Study Conduct/Dosing Plan
Following one week of single-blind b.i.d. placebo
washout, this trial was an eight week, parallel, double blind study; patients
were randomly assigned to receive placebo, or one of two dose levels of
bupropion sustained-release. Patients were
randomized in blocks of six, with equal chances of receiving any of the three
treatments. Medication consisted of
identically-appearing tablets containing either placebo or 50 mg bupropion
sustained-release. Each patient received
a blister card containing a ten day supply of medication each week. After one week for increasing doses,
patients were instructed to take three tablets in the morning and three each
evening and to return the blister card with all unused tablets. On this schedule, patients either received
placebo b.i.d 150 mg bupropion sustained-release qam and placebo qpm, or 150 mg
bupropion sustained-release b.i.d The
investigators were permitted to decrease the dose to a minimum of one tablet
b.i.d. at any time if clinically indicated.
Patients who experienced intolerable adverse effects from a minimum dose
of 1 tablet b.i.d were to be discontinued from the trial. Except for chloral hydrate that was
permitted as a supplement in the first two weeks of the study, concomitant
psychoactive medications were not permissible. Compliance was assessed by weekly review of the blister card.
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