Gehrman 2009.
Methods | Randomized controlled, double blind trial | |
Participants | 41 participants [mean age of 82.9 (SD 7.0), 68.3% female] who had resided on average 18.9 months in long term care settings. Mean education of 14.2 years with SD of 2.5 years. All were diagnosed were Alzheimer Dementia through the use of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association Diagnostic Critieria. MMSE rating: severe. |
|
Interventions | 3 days baseline (no treatment), 10 days treatment (melatonin combined dose of 8.5 mg immediate release and 1.5 mg time release, or placebo), and 5 days follow‐up (no treatment). | |
Outcomes | Cognitive and non‐cognitive changes in MMSE, Agitated Behavior Rating Scale, and Cohen‐Mansfield Agitated Inventory at 10 days post intervention. | |
Notes | Corresponding author: Dr. Sonia Ancoli‐Israel Department of Psychiatry, University of California, San Diego. Email: sancoliisrael@ucsd.edu |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Although the authors identify the study as a double blind trial, information has not been received to date regarding details of the sequence generation. |
Allocation concealment? | Unclear risk | To date, It is not known how allocation concealment was undertaken in the study. |
Blinding? All outcomes | Low risk | Adequate. Those who administered melatonin and assessed outcomes were blind to allocation to the intervention or control group. |
Incomplete outcome data addressed? All outcomes | Unclear risk | Although all participants appear to have completed the randomized control trial, to date, information has not been received from the author to verify 100% completion of the study. |
Free of selective reporting? | Unclear risk | The intervention protocol is available and all of the study's pre‐specified outcomes have been reported in the pre‐specified way. However, it is unclear whether 100% of the study participants completed the study. |
Free of other bias? | Unclear risk | Information regarding potential confounding factors addressed in exclusion criteria or controlled for in the study have not been received from the author. |