| Methods |
Six‐week randomised, double‐blind study |
| Participants |
Patients fulfilling DSM‐III criteria for major depressive disorder, with a score of at least 17 on the first 17 items of the Hamilton Rating Scale for Depression‐21 item (HDRS‐21), a score of at least 8 on the Raskin Depression Scale (RDS), greater than Covi Anxiety Scale (CAS).
Age range: 18‐65 years
Exclusion criteria: history of manic episode, pregnancy, lactation, absence of contraception, glaucoma, chronic urinary retention, brain or other significant organic illness, schizophrenia, other mental illness or severe suicidal risk, recent history (less than 1 year) of alcohol or drug abuse, concurrent treatment with other psychotropic drug including lithium, use of MAOI less of 2 weeks prior the study entry. |
| Interventions |
Fluoxetine: 60 participants
Clomipramine: 60 participants
Fluoxetine dose range: 20‐40 mg/day
Clomipramine dose: 100 mg/day
Chloralzepate (10 mg) for insomnia was allowed |
| Outcomes |
HDRS‐21, CAS, RDS, Patient Global Impression (PGI), Clinical Global Impression (CGI) |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "were randomly allocated", 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 |
Quote: " apparently identical capsules in seven doubles enveloped marked 'morning' and 'midday' dose", 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 |
Unclear risk |
Number and reasons for dropout reported. Scores reported without denominator |
| Selective reporting (reporting bias) |
Unclear risk |
Only most common side effects reported. Baseline and mean changes in efficacy measures reported with standard deviation |
| Other bias |
High risk |
One of the authors' affiliation was Eli Lilly Spain, Madrid; this company produces fluoxetine |
