Armitage 1997.
| Methods | Eight‐week double‐blind, randomised trial | |
| Participants | Patients meeting DSM‐III‐R diagnostic criteria for non psychotic, moderate to severe major depression disorder and a minimum score of 18 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17). All patients were required to have subjective sleep disturbance (score of 1 or 2 on at least one of the sleep items of the HDRS‐17). Age range: 18‐55 years Exclusion criteria: patients with current general medical condition, history of head trauma or current DSM‐III‐R axis I disorder in the categories of organic mental syndromes or disorders, bipolar disorder, schizophrenia, delusional disorder, or psychotic disorder NOS. Shift workers, or those with any evidence of independence sleep disorder (such as narcolepsy, bruxism, sleep apnoea) were ineligible. Patients with a history of psychoactive substance abuse, to be pregnant, lactating, or sexual active without an adequate method of contraception, previous participation in a nefazodone trial, significant suicide risk, or known hypersensitivity to trazodone, etoperidone, fluoxetine or metachlorophenylpiperazine were other exclusion criteria. |
|
| Interventions | Fluoxetine: 22 participants Nefazodone: 12 participants Fluoxetine dose range: 20‐40 mg/day Nefazodone dose range: 400‐500 mg/day | |
| Outcomes | HDRS‐17 total score and sleep parameters | |
| Notes | Funding: by industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised trial, 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 | Low risk | Quote: "double dummy capsule‐dosing scheme" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no further information |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Mean baseline and endpoint scores reported without standard deviations. Number and reasons for dropout specified |
| Selective reporting (reporting bias) | Unclear risk | Side effects not reported |
| Other bias | High risk | This study was supported in part by Bristol‐Myers Squibbs. This company produces nefazodone |