Methods | Eight-week randomised, double-blind study. | |
Participants | Inpatients fulfilling DSM-III-R criteria for major depression with melancholia, with a score of at least 20 on the HDRS-21. Age range: 18-70 years old. Exclusion criteria: known hypersensitivity to clomipramine, narrow angle glaucoma, risk of chronic urinary retention, no improvement or lack of efficacy with previous treatment with clomipramine at least 200 mg/day during 6 weeks, organic brain disease, history of seizures, serious illness including cardiovascular, hepatic, renal, respiratory, hematologic disease, hyperthyroidism, history of severe allergy or multiple adverse drug reaction, recent history of drug or alcohol abuse, concurrent administration of other psychotropic drug except some benzodiazepines, use of MAOI, pregnancy, lactation |
|
Interventions | Fluoxetine: 28 (?) participants. Clomipramine: 26 (?) participants. Fluoxetine dose range: 20-80 mg/day. Clomipramine dose range: 50-200 mg/day. Only oxazepam (50-300 mg/day) as hypnotic or anxiolitic was allowed |
|
Outcomes | Hamilton Rating Scale for Depression (HDRS-21), Montgomery and Asberg Scale for Depression (MADRS), Covi Anxiety Scale | |
Notes | Funding: unclear | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |