Nelson 2004.
| Methods | Six‐week randomised, double‐blind study | |
| Participants | Inpatients with unipolar non‐psychotic major depression, with a score of at least 18 on the Hamilton Rating Scale for Depression (HDRS) after at least one week in the hospital without medication. Age: 21 years and older Exclusion criteria: patients who had more than 30% improvement in the first week remained medication free for two‐weeks and were excluded if the HDRS score drop below 18. Patients with schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression, active medical illness, substance abuse in the past 6 months, and cluster B personality disorder were excluded. | |
| Interventions | Fluoxetine: 14 participants
Desipramine: 12 participants
Fluoxetine + desipramine: 13 participants
Fluoxetine dose: 20 mg/day
Desipramine mean dose: 293 mg/day (SD: 116.8) Fluoxetine + desipramine dose: 20 mg/day fluoxetine + 98,1 (SD: 45.0) desipramine |
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| Outcomes | HDRS, Montgomery and Asberg Scale for Depression (MADRS) | |
| 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 | 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 | High risk | Number and reasons for dropout reported without distinguish the study arms. Score reported without denominator |
| Selective reporting (reporting bias) | Unclear risk | Side effects not reported. End point score on HDRS and MADRS reported with standard deviation |
| Other bias | Low risk | Quote: "this research was supported in part by National Institute of Mental Health Grants R01‐MH‐47894 and MH‐30020" |