Da Silva (nAD) 2005.
| Study characteristics | ||
| Methods | Pilot randomised controlled parallel‐arm trial, 12 weeks Participants split across Da Silva (AD) 2005 and Da Silva (nAD) 2005, depending on antidepressant use, prior to randomisation |
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| Participants |
Participants: 31 participants, with a mean age = 64.4 (range 49 ‐ 78) years, 58% women (split across Da Silva (AD) 2005 and Da Silva (nAD) 2005). Participants were selected from Association of Patients with Parkinson's disease of Paraná, Curitiba, Brazil, dates ‐ not reported. Comorbidities: Parkinson's disease (PD), other possible comorbidities Adjunctive therapy: No for all participants Inclusion criteria: Parkinsons disease, DSM‐IV criteria for MDD (MINI plus, and a SCID), score < 2.5 Hoehn & Yahr scale for PD (Hoehn 1967), no signs of dementia (MMSE) (Folstein 1975), UPDRS assessment (Taylor 2005), taking medication for depression for at least 1 yr or refused to take medication Exclusion criteria: initiated antidepressant use after diagnosis, cognitive and memory declines, drug/alcohol dependent. Any participant who presented with an alteration of PD (above 0.5 point on Hoehn and Yahr scale) after 3 months was also excluded |
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| Interventions |
Intervention: EPA/DHA combination (720 mg/d EPA, 480 mg/d DHA, plus tocopherols), 4 capsules Comparator: Mineral oil, 4 capsules/d Treatment received for 3 months |
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| Outcomes |
Primary: MADRS, BDI assessed at baseline and 12 weeks, Adverse events Secondary: Response based on MADRS, CGI assessed at baseline and 12 weeks, Trial non‐completion |
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| Notes |
No funding reported. Supplements provided by Herbarium Foundation for Health and Research Conflicts of interest: None declared Compliance: RBC membrane levels of EPA and DHA assessed before and after treatment Depressed mood (continuous): Analysis conducted on MADRS scores at 12 weeks, per protocol data provided by authors Adverse events: 2 individuals reported adverse events ‐ 1 GI, 1 other physical (split across Da Silva (AD) 2005 and Da Silva (nAD) 2005 ‐ group not reported). Values could not be included in analysis Response (50% improvement in MADRS score) ‐ Intervention group = 42%, comparator group = 6% (split across Da Silva (AD) 2005 and Da Silva (nAD) 2005 ‐ group not reported). Values could not be included in analysis Quality of Life: Analysis conducted on CGI Trial non‐completion: 2 individuals withdrew (split across Da Silva (AD) 2005 and Da Silva (nAD) 2005 ‐ group not reported) Values could not be included in analysis. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done by drawing (additional information from the author) |
| Allocation concealment (selection bias) | Unclear risk | "Identification of the groups and separation of the respective capsules were carried out in the _ laboratory at University Federal do Parana" (P.353) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither researcher or participants knew which substance was given (identical placebo). Not reported if the fishy taste was disguised, and no assessment to check concealment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | MADRS and BDI (both evaluated by trained psychologist blinded to allocation) (P.353) |
| Blinding of outcome assessment (Adverse Events) | Unclear risk | Adverse events ‐ unclear whether these were reported by clinicians or participants |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Data not ITT |
| Incomplete outcome data (Adverse Events) | Unclear risk | AEs were not clearly reported |
| Selective reporting (reporting bias) | Low risk | All depression data reported (additional information from author) |
| Other bias | Low risk | Study appeared to be free from other sources of bias. |