Flint AJ, Rifat SL. Recurrence of first-episode geriatric depression after discontinuation of maintenance. American Journal of Psychiatry 1999;156:943-43
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/10360137
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 21 enrolled, 21 completed
Age: 74.4 ± 6.6 years Sex: Not described Participants with dementia: No Inclusion criteria: · Treated for a first-lifetimeepisode of DSM-III-R unipolar non-psychotic major depression o 17-item Hamilton Depression Rating Scale score of 16 or above o Episode of depression had responded (Hamilton depression scale score of ten or below) to either § Nortriptyline (with or without adjunctive lithium) as the first-line of treatment n=19, or § Phenelzine as second-line of treatment n=2 · Been on maintenance regimens of the medications that they had responded to · Remained free of relapse or recurrence of major depression for 2 years from the time of response Exclusion criteria: · History of major depression was determined by responses to questions in the Structured Clinical Interview for DSM-III-R and by collateral history obtained from reliable informants · Concurrent axis I diagnosis; a lifetime history of schizophrenia, schizoaffective disorder, paranoid disorder, or dementia; any neurological disorder affecting the central nervous system · Acute uncontrolled medical illness Country: Canada Setting: Not described |
| Interventions | Medicine:
· Nortriptyline as first-line therapy; or · Phenelzine as second-line therapy Withdrawal schedule: Antidepressant medication and, when applicable, adjunctive lithium withdrawn over a period of 8 weeks |
| Outcomes | Depression recurrence
Predictors of recurrence Response to re-introduction of therapy |
| Dates | Dates: Not described
Follow-up duration: 24 months |
| Funding sources | The Queen Elizabeth Hospital Research Institute. |
| Notes | Short report – limited detail |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | This was a before-and-after study, not a randomized design. |
| Allocation concealment (selection bias) | High risk | There was no concurrent control group. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | This was an open study. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | As above. |
| Incomplete outcome data (attrition bias) | 5 out of 5 | Many values are not reported on numerically.
Results are not reported – only results of statistical tests. Participant numbers do not add up. The other nine participants that were enrolled intothe study are not reported. Results are not reported – only results of statistical tests. |
| Selective reporting (reporting bias) | 5 out of 5 | Kaplan–Meier survival curve was done but not reported on – probably due to space with a short report.
There probably was a pre-specified protocol and analysis plan, but the article does not make this clear. |
| Confounding (non-randomized) | 5 out of 5 | There was no concurrent control group.
Gender not stated – what percentage were male and female. Setting – community, residential aged care facility, hospital? No mention was made of development of other illnesses either medical or psychiatric during the follow-upperiod, social circumstances, gender. |
| Other bias | High risk | Insufficient detail.
For a study that was run during the mid to late 1990s, to limit the study to nortriptyline and phenelzine is surprising. As shown below, many social measures were considered but not reported. · Hamilton depression scale, anxiety sub-scale of the Hospital Anxiety and Depression Scale · MMSE · Life Events and Difficulties Schedule modified for the elderly · The physical illness rating scale of Burvill et al. |
| Selection bias | Representativeness of the exposed cohort | Insufficient detail to know if the cohort was a representative cohort. For example, the setting (e.g. community or hospital) and gender unknown. |
| Selection of the non-exposed cohort | There was no concurrent control group.
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| Ascertainment of exposure | Ascertainment of exposure was through the securerecord. | |
| Demonstration that outcome of interest was not present at start of study | Yes. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controls for deprescribing antidepressant therapy using the before-and-after outcomes as the control. |
| Outcome bias | Assessment of outcome | The outcome was assessed by record linkage. |
| Was follow-up long enough for outcomes to occur | The follow-up duration was probably long enough for outcomes to occur.
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| Adequacy of follow-up of cohorts | Follow-up rate was 60%. There was no description of those lost. |
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