7.2.1.2                  Study Plan

 

7.2.1.2.1             Objectives/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.

 

7.2.1.2.2             Population

 

·         The following summarizes inclusion criteria for the study:

·         Age greater than 17 years old

·         Good physical health

·         Meeting DSM-III-R criteria for Major Depressive Disorder, with a current Major Depressive Episode of between four weeks and two years duration

·         Score of at least 20 on the first 17 items of the 28-item Hamilton Depression Scale (HAMD) at both time of screening and after one week of placebo washout, with a drop of not more than 20 per cent over the 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 diagnosis that would suggest non-responsiveness to pharmacotherapy for depression

·         History of diagnosis of anorexia or bulimia

·         Presence of medical disorder that would interfere with drug levels or with the accurate assessment of depression

·         Females who were pregnant, breast-feeding, or unwilling to employ appropriate contraceptive methods during the study.

·         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 protiptyline 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.

 

 

7.2.1.2.3              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 150 mg bupropion sustained-release.  Each patient received a blister card containing a ten day supply of medication each week.  They were instructed to take one tablet in the morning and one 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.  To adjust to the dosage, patients in the latter group received placebo in the evening for the first three days of the study.  Patients who experienced intolerable adverse effects from their assigned dose 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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