Montgomery 1988.
| Study characteristics | ||
| Methods |
Design: multi‐centre multi‐phase double‐blind randomised placebo‐controlled trial Prerandomisation phase Phase 1: acute treatment with fluoxetine 40 to 80 mg (6 weeks) Phase 2: continuation treatment with a stabilised dose of 40 mg at 24 weeks (18 weeks) Duration post randomisation: 52 weeks Aim: to test the efficacy of fluoxetine in preventing recurrence of new episodes among patients with major unipolar recurrent depression |
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| Participants |
Country: France Setting: 5 centres Type of AD: fluoxetine Duration of antidepressant treatment prerandomisation: 24 weeks Duration of antidepressant treatment post stabilisation: 18 weeks Number of participants: 456 entered phase 1, 254 responded to phase 1 Total numbers of randomised participants: 220 (112 placebo, 108 fluoxetine) Primary diagnosis: major unipolar recurrent depression Number of previous episodes last 5 years, mean (SD): 3.6 (3.1) placebo, 4.0 (4.8) antidepressant Gender distribution (male): not reported Mean age, years (SD): not reported Severity of depressive symptoms at randomisation: HDRS not reported Inclusion criteria ‐ MDD (DSM‐III), score > 18 HDRS, ≥ 1 major episode in last 5 years with interval ≥ 6 months between end of previous and start of present episode ‐ response in the first 6 weeks of acute treatment; remained in remission during continuation treatment ‐ definition of response: HDRS score < 12 Exclusion criteria ‐ history of manic episodes or received lithium during last 5 years |
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| Interventions |
Intervention 1: placebo Tapering scheme: abrupt probably ("results consistent with suggestion withdrawn abruptly") Intervention 2: fluoxetine 40 mg/d No concomitant psychotropic medication was permitted, with the exception of benzodiazepines |
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| Outcomes |
Primary outcome ‐ recurrence of depression ‐ definition of relapse: HAM‐D > 18 Secondary outcome ‐ none |
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| Notes |
Funding: not reported COI: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “patients were randomly assigned” Comment: information insufficient to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Comment: information insufficient to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind" Comment: information insufficient to permit judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: information insufficient to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 38/220 dropouts (20/112 placebo, 18/108 antidepressant) but reasons not stated according to group |
| Selective reporting (reporting bias) | High risk | Comment: study report fails to include results for adverse events and withdrawal symptoms that would be expected to have been reported for such a study. None of our secondary outcomes were reported |
| Other bias | Unclear risk | Comment: source of funding not reported |