Stahl 2000.
Methods | Twenty‐four‐week, eight centres, double‐blind randomised trial. | |
Participants | Patients who satisfied DSM‐IV criteria for Major Depressive Disorder (MDD) with a minimum 2 months duration of illness, with a score of at least 22 on the Hamilton Depression Rating Scale (HDRS) , a minimum score of 2 on Depressed Mood Item and a minimum score of 8 on Raskin Depression Scale together with a lower score on the Covi Anxiety Scale.
Age range: 18‐60 years old. Exclusion criteria: pregnancy, inadequate contraception, another DSM‐IV Axis I diagnosis, use of other psychotropic medication, increased risk of suicide, treatment resistance, history of sertraline intolerance or SSRI hypersensitivity reactions, history of alcohol or substance abuse. |
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Interventions | Sertraline: 108 participants. Citalopram: 107 participants. Placebo: 108 participants. Sertraline dose range: 50‐150 mg/day. Citalopram dose range: 20‐60 mg/day. Chloral Hydrate was permitted. | |
Outcomes | 21‐HDRS, MADRS, Clinical Global Impression‐Severity (CGI‐S) andClinical Global Impression‐Improvement (CGI‐I), Hamilton Anxiety Scale (HAM‐A), Symptom Checklist‐56 (SCL‐56), Quality of Life Enjoyment and Satisfaction Questionnaire (Q‐LES‐Q). | |
Notes | This study was funded by Lundbeck (citalopram manufacturer). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "randomized". Probably done, as a similar trial by these investigators included the same phrase and used a proper method of allocation. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote "double‐blind" but authors did not give other information. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing data and standard deviations. |
Selective reporting (reporting bias) | Unclear risk | The study protocol is not available. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |