Navarro 2001.
Methods | Twelve‐week, randomised, single‐blind study. | |
Participants | In‐ and out‐patients with unipolar major depression fulfilling the DSM‐IV criteria for a current major depressive episode, with or without endogenous or psychotic features. Only elderly patients with late‐onset depression were included (depression late‐onset had to have begun after the age of 50). Age: 60 years or over. Exclusion criteria: patients with significant abnormal biological findings on electrocardiographic or laboratory examination, those with focal neurological findings or systemic neurological disorder (e.g. seizure disorders, stroke, Parkinson's disease) and those with uncontrolled medical illness at the time of recruitment. Patients with a manic or hypomanic episode, any history of psychosis, current substance dependence and electroconvulsive therapy within 6 months of recruitment. |
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Interventions | Citalopram: 29 participants. Nortriptyline: 29 participants. Citalopram dose range: 30‐40 mg/day (mean dose: 33.45; SD 4.84) Nortriptyline dose range: 50‐100 mg/day (mean dose: 61.11; SD 17.45) Lorazepam up to 4 mg/day was allowed for management of anxiety or insomnia. |
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Outcomes | Primary outcome: mean change in Hamilton Depression Rating Scale (HDRS) score from baseline to endpoint. | |
Notes | Six patients with psychotic symptoms (two in nortriptyline group and four in citalopram group) received haloperidol up to 4 mg/day during the first 4 weeks. Eligible patients underwent a 2‐week washout period. Rapid wash‐out responders (HDRS decreased by 25% or more) were excluded from the study. This study was partially supported by a research grant from the Investicacions Biomediques August Pi i Sunyer Institut (IDIBAPS) to Victor Navarro and by FIS grant 99/0171. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "subjects were randomly divided into two subgroups". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "single‐blind", but author not give other information. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "statistical analyses of safety data were conducted on all patients randomized to treatment who took at last one dose of study medication. Efficacy analyses included all modified intent to treat patients: that is all patients randomized to treatment who took their assigned medication for 4 weeks or more". |
Selective reporting (reporting bias) | Unclear risk | No reliable data provided. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |