drugset / Trial / NCT00898807
Citalopram for Agitation in Alzheimer's Disease
Phase 3
Completed
186 enrolled
JHSPH Center for Clinical Trials
National Institute of Mental Health (NIMH) · collabNational Institute on Aging (NIA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
Timeline
- Start
- 2009-07
- Primary completion
- 2013-09
- Completion
- 2013-09
Outcome
Met primary endpoint
paper Participants who received citalopram showed significant improvement compared with those who received placebo on both primary outcome measures. PMID 24549548 ↗
registry Citalopram and Psychosocial Intervention vs Placebo and Psychosocial Intervention; p = 0.036; Mean Difference (Net) -0.93 (95% CI -1.80 to -0.06) NCT00898807 ↗
registry Citalopram and Psychosocial Intervention vs Placebo and Psychosocial Intervention; p = 0.007; Odds Ratio (OR) 2.13 (95% CI 1.23 to 3.69) NCT00898807 ↗
Publications
- Background Drye LT, Ismail Z, Porsteinsson AP, Rosenberg PB, Weintraub D, Marano C, Pelton G, Frangakis C, Rabins PV, Munro CA, Meinert CL, Devanand DP, Yesavage J, Mintzer JE, Schneider LS, Pollock BG, Lyketsos CG; CitAD Research Group. Citalopram for agitation in Alzheimer's disease: design and methods. Alzheimers Dement. 2012;8(2):121-30. doi: 10.1016/j.jalz.2011.01.007. Epub 2012 Feb 1.
- Results Porsteinsson AP, Drye LT, Pollock BG, Devanand DP, Frangakis C, Ismail Z, Marano C, Meinert CL, Mintzer JE, Munro CA, Pelton G, Rabins PV, Rosenberg PB, Schneider LS, Shade DM, Weintraub D, Yesavage J, Lyketsos CG; CitAD Research Group. Effect of citalopram on agitation in Alzheimer disease: the CitAD randomized clinical trial. JAMA. 2014 Feb 19;311(7):682-91. doi: 10.1001/jama.2014.93.
- Drye LT, Spragg D, Devanand DP, Frangakis C, Marano C, Meinert CL, Mintzer JE, Munro CA, Pelton G, Pollock BG, Porsteinsson AP, Rabins PV, Rosenberg PB, Schneider LS, Shade DM, Weintraub D, Yesavage J, Lyketsos CG; CitAD Research Group. Changes in QTc interval in the citalopram for agitation in Alzheimer's disease (CitAD) randomized trial. PLoS One. 2014 Jun 10;9(6):e98426. doi: 10.1371/journal.pone.0098426. eCollection 2014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Citalopram | Small molecule | 30 mg | Oral |