Bennie 1995.
Methods | Six‐week double‐blind, randomised multicentre study | |
Participants | Outpatients with a diagnosis of major depression or bipolar disorder, depressed, according to DSM‐III‐R, scoring at least 18 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17), and with a higher on the Raskin Depression Scale than on the Covi Anxiety Scale. Age: over 18 years Exclusion criteria: pregnant or lactating women, women of childbearing potential not practicing a reliable method of contraception, patients with previous treatment with sertraline or fluoxetine, treated with MAOI within two weeks or other antidepressants medication within one week of double‐blind therapy, treated with reserpine or methyl‐dopa, likely to require additional treatments with psychoactive medication, ECT or intensive psychotherapy during the study; failure to respond to previous antidepressant therapy at clinically appropriate dosages, use of ECT to treat a previous episode of depression, a history of severe allergies or multiple adverse events associated with pharmacotherapy, the presence of significant medical disease; psychiatric history including another Axis I disorder and significant suicide risk. | |
Interventions | Fluoxetine: 144 participants Sertraline: 142 participants Fluoxetine dose range: 20‐40 mg/day Sertraline dose range: 50‐100 mg/day Chloral hydrate (max 1 g) and temazepam (max 20 mg) were allowed as hypnotic | |
Outcomes | Primary outcome: HDRS‐17, Clinical Global Impression Severity and Improvement Scales (CGI S‐I) Secondary outcomes: Hamilton Rating Scale for Anxiety, the Raskin Depression Scale and Covi Anxiety Scale, self‐rated Leeds Sleep Questionnaire | |
Notes | Patients with concomitant medical conditions were allowed to participate in the study provided that the conditions were clearly not associated with the illness of the study and that any required medications were not psychoactive agents. One patient attempted suicide in the fluoxetine group. Funding: by industry |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned, in equal proportion", no other information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no further information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double blind, no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no further information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number and reasons for dropout reported. Scores reported with denominator |
Selective reporting (reporting bias) | Unclear risk | Scores reported without standard deviations. Only adverse events occurring at least in 3% of the sample reported |
Other bias | High risk | Quote: "supported by a research grant from international Pharmaceuticals group, Pfizer, Inc, New York". This company produces sertraline |