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. 2010 Mar 17;2010(3):CD006114. doi: 10.1002/14651858.CD006114.pub2

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.
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.
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.