O5‐06‐06: Changes in QTC Interval in the Citalopram for Agitation in Alzheimer's Disease (Citad) Randomized Trial

Porsteinsson, Anton P.; Drye, Lea T.; Spragg, David D.; Devanand, Davangere; Frangakis, Constantine; Marano, Christopher; Meinert, Curtis L.; Mintzer, Jacobo; Munro, Cynthia A.; Pelton, Gregory H.; Pollock, Bruce G.; Rabins, Peter V.; Rosenberg, Paul B.; Schneider, Lon S.; Shade, David M.; Weintraub, Daniel; Yesavage, Jerome A.

doi:10.1016/j.jalz.2014.04.511

Cited by 29 publications

(57 citation statements)

References 15 publications

(22 reference statements)

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“…Taking into account this limitation associated with this specific patient population, we have included a sample that is representative for the majority of the target population with clinically relevant NPS; the level of behavioral disturbances, assessed by NPI, was moderate and comparable to previous intervention trials. [33][34][35] We observed an improvement in NPS in both groups over the duration of the study period, which has been reported before. 34,35 The substantial degree of improvement in the placebo group is striking (table 2), and may be due to many factors including attention and support by the study team, expectations of patients and caregivers concerning THC, and training of nursing home Table 2 Overview of study results of the application of THC on neuropsychiatric symptoms in dementia personnel (together called the Hawthorne or instudy effect 36 ).…”

Section: Classification Of Evidence This Interventional Study Providessupporting

confidence: 87%

Tetrahydrocannabinol for neuropsychiatric symptoms in dementia

et al. 2015

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Objective: To study the efficacy and safety of low-dose oral tetrahydrocannabinol (THC) in the treatment of dementia-related neuropsychiatric symptoms (NPS).Methods: This is a randomized, double-blind, placebo-controlled study. Patients with dementia and clinically relevant NPS were randomly assigned to receive THC 1.5 mg or matched placebo (1:1) 3 times daily for 3 weeks. Primary outcome was change in Neuropsychiatric Inventory (NPI), assessed at baseline and after 14 and 21 days. Analyses were based on intention-to-treat.Results: Twenty-four patients received THC and 26 received placebo. NPS were reduced during both treatment conditions. The difference in reduction from baseline between THC and placebo was not significant (mean difference NPI total : 3.2, 95% confidence interval [CI] 23.6 to 10.0), nor were changes in scores for agitation (Cohen-Mansfield Agitation Inventory 4.6, 95% CI 23.0 to 12.2), quality of life (Quality of Life-Alzheimer's Disease 20.5, 95% CI 22.6 to 1.6), or activities of daily living (Barthel Index 0.6, 95% CI 20.8 to 1.9). The number of patients experiencing mild or moderate adverse events was similar (THC, n 5 16; placebo, n 5 14, p 5 0.36). No effects on vital signs, weight, or episodic memory were observed.Conclusions: Oral THC of 4.5 mg daily showed no benefit in NPS, but was well-tolerated, which adds valuable knowledge to the scarce evidence on THC in dementia. The benign adverse event profile of this dosage allows study of whether higher doses are efficacious and equally welltolerated. Classification of evidence:This study provides Class I evidence that for patients with dementiarelated NPS, low-dose THC does not significantly reduce NPS at 21 days, though it is welltolerated. Neurology ® 2015;84:2338-2346 GLOSSARY AD 5 Alzheimer disease; AE 5 adverse event; CCGIC 5 Caregiver Clinical Global Impression of Change; CI 5 confidence interval; CMAI 5 Cohen-Mansfield Agitation Inventory; NPI 5 Neuropsychiatric Inventory; NPS 5 neuropsychiatric symptoms; PAL WMS-R 5 Paired Associate Learning Wechsler Memory Scale-Revised; QoL-AD 5 Quality of Life-Alzheimer's Disease Scale; RCT 5 randomized controlled trial; THC 5 D-9-tetrahydrocannabinol.

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Section: Classification Of Evidence This Interventional Study Providessupporting

confidence: 87%

Tetrahydrocannabinol for neuropsychiatric symptoms in dementia

et al. 2015

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“…29 A trial of selective serotonin reuptake inhibitors is recommended for agitation; the strongest evidence is for citalopram. 30 The role of antidepressants in the treatment of depression in people with dementia is uncertain. Larger trials conducted in people with dementia have not shown benefit (in group data) for antidepressants for treatment of depression per se.…”

Section: Changes In Managementmentioning

confidence: 99%

Clinical practice guidelines for dementia in Australia

Laver

Cumming

Dyer

et al. 2016

Medical Journal of Australia

100

115

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“…Beneficial effects have been reported for some anti-dementia 286 E. Savaskan et al drugs (cholinesterase inhibitors, memantine), anti-depressants (Gauthier et al, 2010), and some antipsychotics (Tan et al, 2015). Specific effects of citalopram in patients with agitation associated with AD have been reported (Porsteinsson et al, 2014).…”

Section: Introductionmentioning

confidence: 99%