Mowla 2006.
Methods | Eight‐week randomised, double‐blind study | |
Participants | Outpatients fulfilling DSM‐IV criteria for major depression disorder, based on a structured clinical interview. Mean age: 30.8 (SD: 9.9) (fluoxetine) and 35 (SD: 9.4) (nortriptyline) years Exclusion criteria: patients with another DSM‐IV diagnosis, psychotic symptoms, alcohol or other drugs addiction, major physical illness, potentially pregnant women, breast‐feeding or planning to be pregnant in the next two months, patients in whom tricyclics were contraindicated (i.e. narrow‐angle glaucoma, prostatism). | |
Interventions | Fluoxetine: 36 participants Nortriptyline : 20 participants Fluoxetine dose: 40 mg/day Nortriptyline dose: 150 mg/day |
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Outcomes | Primary outcomes: change in Hamilton Rating Scale for Depression (HDRS) and in Clinical Global Impression (CGI) total scores | |
Notes | Funding: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further information |
Allocation concealment (selection bias) | Unclear risk | No information provided |
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 | Quote: "the investigator was blind as to medications and he did not personally manage any patients in the study", 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 | High risk | Number of dropouts was reported, but the reasons were not clearly described. Endpoint scores not reported (HDRS, CGI) |
Selective reporting (reporting bias) | High risk | Side effects not reported. Item in which there was significant improvement reported without mean and standard deviation |
Other bias | Unclear risk | Funding: unclear |