Moore 2005.
Methods | Eight‐week, double‐blind, prospective, multicentre, randomised study. | |
Participants | Outpatients meeting DSM‐IV criteria for Major Depressive Disorder (MDD) and having a Montgomery‐Asberg Depression Rating Scale (MADRS) total score at baseline of at least 30. Age range: 18‐65 years. Exclusion criteria: patients meeting criteria for primary diagnoses of any axis I disorder other than MDD, or those with a history of mania, bipolar disorder, schizophrenia or other psychotic disorder, obsessive‐ compulsive disorder, cognitive disorder including mental retardation or personality disorder. Patients who met DSM criteria for substance abuse or dependence within the past 12 months, or who used a depot antipsychotic within 6 months before study inclusion, or any antipsychotic, anxiolytic or anticonvulsant medication within 2 weeks before the first administration of study medication. |
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Interventions | Escitalopram: 138 participants. Citalopram: 142 participants. Escitalopram fixed dose: 20 mg/day. Citalopram fixed dose: 40 mg/day. |
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Outcomes | Primary outcome: mean change from baseline to endpoint on the MADRS. Change from baseline to last assessment score in the Clinical Global Impression‐Severity Scale (CGI‐S). |
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Notes | This study was funding by H. Lundbeck A/S. One suicide completed in citalopram group after 12 days of treatment. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients meeting eligibility criteria were randomly assigned (...) with equal block randomization at baseline". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "double‐blind" but author not give other information. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Efficacy analysis on Intention‐to‐treat (ITT) population (all patients who took at least one dose of study medication and who had at least one valid post‐baseline MADRS assessment). |
Selective reporting (reporting bias) | High risk | Many rating scales listed in Methods, but only a few reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |