Ulfvarson J, Adami J, Wredling R, et al. Controlled withdrawal of selective serotonin reuptake inhibitor drugs in elderly patients in nursing homes with no indication of depression. European Journal of Clinical Pharmacology 2003;59:735-40.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/14595527
Full text article: https://link.springer.com/article/10.1007%2Fs00228-003-0687-y
| Methods | Study design: Open-label randomized placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 70 randomized
· Intervention deprescribing group, 35 randomized · Control group: 35 randomized Age: 84.1 ± 7.8 years Sex: 47 female, 23 male Participants with dementia: No Inclusion criteria: · Residents of participating aged care facilities · Older than 75 years · Treated with SSRI drugs for more than 6 months · Without any documented indication or symptoms of depression or anxiety disorder according to the DSM-IV diagnostic criteria · Montgomery-Asberg Depression Rating Scale score less than or equal to 12 Exclusion criteria: · Dementia · History of depression or anxiety Concurrent medicines: 7.1 ± 2.2 Country: Sweden Setting: Residential aged care facilities – Stockholm area of Sweden, 11 nursing homes, with a total of 800 patients |
| Interventions | Medicine: antidepressants (citalopram 10mg n=4, citalopram 20mg n=25, citalopram 30mg n=1, citalopram 40mg n=2, sertraline 50mg n=2, sertraline 100mg n=1)
Duration of therapy before study: 2.4 +/- 1.5 years Withdrawal schedule: Halving the dose for a few days before cessation |
| Outcomes | Montgomery-Asberg depression rating scale
Global assessment of functioning Health index Symptom assessment form Symptoms of side effects of SSRI drug treatment Death at one year |
| Dates | Dates: Not described
Follow-up duration: 12 months |
| Funding sources | The authors state, “We are grateful to The Swedish Foundation for Health Care Sciences and Allergy Research and the Federation of County Councils, Stockholm County Council, R&D Department.” It is probable this is the funding source, but this is not explicitly stated. |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | “The process of randomization was performed by closed, unmarked envelopes containing a note stating either ‘‘intervention’’ or ‘‘control’’. Stratification for sex was not performed.” |
| Allocation concealment (selection bias) | Unclear risk | Not described, nor is the study claimed to be blinded.
The process of randomization was performed by closed, unmarked envelopes containing a note stating either ‘‘intervention’’ or ‘‘control’’. |
| Blinding of participants and personnel (performance bias) | High risk | As above |
| Blinding of outcome assessment (detection bias) | High risk | As above |
| Incomplete outcome data (attrition bias) | High risk | The analysis is as-treated. |
| Selective reporting (reporting bias) | Low risk | There is evidence of a pre-specified protocolthough this was not published publicly. The stated objectives are reported. |
| Other bias | Low risk | Not identified. |
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