Hsu 2011.
Methods | Six‐week, randomised, double‐blind study. | |
Participants | Outpatients aged between 20 and 65 years, who met the DSM‐IV criteria for MDD, experiencing a drug naive first depressive episode, exhibited a total score on the Montgomery‐Asberg Depression Rating Scale (MADRS) (MADRS of > or = 25 at screening, and displayed a < or = 20% decrease in MADRS score between screening and baseline visits). Patients were excluded from the trial if they had a history of severe allergy or major medical illness. Were also excluded patients who displayed acutely suicidal tendencies, or had a history of drug or alcohol dependence or abuse. In addition, patients were excluded if they had previously received treatment of any antidepressant or had taken monoamine oxidase inhibitors. Women who were pregnant, lactating, and women with childbearing potential who were not using a medically acceptable form of contraception were also excluded. |
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Interventions | Citalopram: 25 participants. Sertraline: 26 participants. Citalopram dose: 20 mg/day. Setraline dose: 50 mg/day. |
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Outcomes | Primary outcomes: MADRS total score, response and remission rates. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned". Likely done |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "The primary efficacy end points were the mean difference in MADRS total score at baseline and weeks 1, 3, and 6. Other efficacy end points included the percentage of patients with MADRS remission (MADRS total scores e10) and response (Q50% reduction from randomization in MADRS total score) at treatment week 6. Tolerability was assessed as the percentage of patients who developed specific adverse events during the treatment period." |
Selective reporting (reporting bias) | High risk | MADRS scores were reported only in figures. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |