| Methods |
Six‐week double‐blind, randomised, two‐site study |
| Participants |
Inpatients fulfilling DSM‐III‐R criteria for major depressive disorder without psychotic features, with a score of at least 18 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 18‐70 years
Exclusion criteria: high suicide risk, other psychiatric diagnosis, somatic disease which could contraindicate treatment with fluoxetine or maprotiline, history of hypersensitivity, severe allergies, multiple severe reactions to drugs, lactation, pregnancy or pregnancy wish, MAOI use within 2 weeks before starting the trial. |
| Interventions |
Fluoxetine: 30 participants
Maprotiline: 35 participants
Fluoxetine dose range: 40‐80 mg/day
Maprotiline dose range: 50‐150 mg/day
Only oxazepam was allowed as hypnotic or anxiolytic, if absolutely required |
| Outcomes |
HDRS‐17, Raskin Depression Scale (RDS), Covi Anxiety Scale (CAS), Clinical Global Impression (CGI) Severity and Improvement |
| Notes |
Funding: by industry |
| 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 |
Unclear risk |
Rating scale scores reported without denominator. Number and reasons of dropouts reported |
| Selective reporting (reporting bias) |
Unclear risk |
Vital signs not reported |
| Other bias |
High risk |
Quote: "the study was supported by Eli Lilly Nederlands". This company produces fluoxetine |
