Dick 1983.
Methods | Four‐week double blind, randomised study. | |
Participants | Psychiatric inpatients suffering from persistent alteration of mood (depressed mood), had to be accompanied by at least 5 characteristics as mentioned in the Feighner criteria, with a minimum baseline score of 16 on the HRSD‐17. Age range: 34‐64 years old. Exclusion criteria: not stated. | |
Interventions | Fluvoxamine: 17 participants.
Clomipramine: 15 participants.
Fluvoxamine dose: 150 mg/day.
Clomipramine dose: 150 mg/day. The protocol did not allow drugs other than the study medication during the study period except, if necessary, limited use of diazepam, levomepromazine (methotrimeprazine) and flunitrazepam. |
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Outcomes | HRSD‐17, CGI‐S, CGI‐change in condition score and a self rating scale. Total dropout, dropout due to inefficiency, dropout due to side effects, number of patients experiencing at least one side effect, side effect profile. |
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Funded by pharmaceutical companies | Unclear. | |
Fluvoxamine as an investigational or comparator drug | As an investigational drug. | |
Notes | Patients with depression (Feighner criteria) were included, so there might be some bipolar depression, but correct number was not reported. *The HRSD‐17 items 'genital symptoms' and 'loss of weight' were not recorded, study authors analysed left 15 items only. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized", no further details. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "double blind", no further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study endpoint: 4/17 missing from fluvoxamine group (2 due to adverse effects); 4/15 missing from control group (1 due to adverse effects). |
Selective reporting (reporting bias) | High risk | SDs of change score for depression were not reported. |