Lu 10‐171, 83‐01.
Methods | Six‐week, randomised, double‐blind study. | |
Participants | In‐and outpatients of either sex, 18‐65 years old, who had given their informed consent to participate in the study, and who were suffering from a major depressive episode (DSM‐III classification) of a severity corresponding to a total score of at least 18 points on the HDRS‐17 items. Exclusion criteria: concurrent somatic disease (particularly severe liver, heart or kidney disease); pregnancy or absence of use of an effective contraceptive method; a history of epilepsy, glaucoma, urinary retention, alcoholism, pyloric stenosis or symptomatic prostatic hypertrophy, marked mental subnormality, need of ECT or administration of ECT during the previous month, treatment with TCA in adequate dosage (100 mg/day of amitriptyline or equivalent) during the last month or with a MAO‐I during the last 2 weeks prior to entry into the study. |
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Interventions | Citalopram: 23 participants. Citalopram dose range: 20‐60 mg/day. Imipramine: 22 participants. Imipramine dose range: 50‐150 mg/day. |
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Outcomes | Outcomes: Change from baseline to week 6 in HDRS‐17 items, Leeds self rating scale. | |
Notes | This study was funded by Lundbeck. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the randomization was made in block of 4 according to a code prepared by the Biostatistical Department of Lundbeck". |
Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "double blind study". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information reported. |
Selective reporting (reporting bias) | Unclear risk | No information reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |