Methods | Eight-week, double-blind, randomised, multicentre study followed by a 1 week, single-blind, down-titration period | |
Participants | Outpatients meeting DSM-IV criteria for Major Depressive Disorder, having a minimum score of 18 on Montgomery-Asberg Depression Rating Scale (MADRS). Age range: 18-85 years. Exclusion criteria: history of mania or any bipolar disorder, schizophrenia or any psychotic disorder, currently obsessive-compulsive disorder, eating disorders, mental retardation, any pervasive development disorder or cognitive disorder, MADRS score >= 5 on item 10, alcohol or drug abuse problems within the past 12 months, concomitant treatment with antipsychotics, antidepressants, psychotropics, serotonin receptor agonists, lithium, carbamazepine, valproate, valpromide, electroconvulsive treatment, behaviour treatment or psychotherapy, pregnancy, breast feeding, use of medications thought likely to interfere with the study |
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Interventions | Escitalopram: 148 participants. Venlafaxine XR: 145 participants. Escitalopram dose range: 10-20 mg/day. Venlafaxine XR dose range: 75-150 mg/day. Zolpidem or stable low doses of Benzodiazepines for insomnia were allowed |
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Outcomes | Primary Outcome: Change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale. Secondary Outcomes: Hamilton Depression Rating Scale (24 item and 17 item), HAMD Subscale Scores (anxiety/somatization, psychomotor retardation, sleep disturbance, cognitive disturbance and melancholia), Clinical Global Impression - Improvement, Clinical Global Impression - Severity |
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Notes | Remission: a score equal or less than 12 on MADRS. This study was funded by escitalopram manufacturer. |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Quote: “randomized”. Probably done |
Allocation concealment? | Unclear | No information provided |
Blinding? All outcomes |
Unclear | No information provided |
Incomplete outcome data addressed? All outcomes |
Yes | Quote: “ITT population included all randomized patients who took at least one dose of double-blind study product and who had at least one valid post-baseline MADRS assessment.” |
Free of selective reporting? | No |