Evidence map›Paper›PMID 21845596›Full record

Trial reportInternational journal of geriatric psychiatry2011

A 6-month, randomized, double-blind, placebo-controlled pilot discontinuation trial following response to haloperidol treatment of psychosis and agitation in Alzheimer's disease.

D P Devanand, Gregory H Pelton, Karine Cunqueiro, Harold A Sackeim, Karen Marder

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of geriatric psychiatry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00009217 (Treatment of Behavioral Symptoms in Alzheimer's Disease), which is not on this map. Cited by 25 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 7 pooled it
3.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00009217 phase4completednot on this map

Treatment of Behavioral Symptoms in Alzheimer's Disease

TypeinterventionalSponsorNew York State Psychiatric InstituteRan1999 to 2004Enrolled44ConditionsAlzheimer's Disease, Psychosis, AgitationArmsHaloperidol-Haloperidol, Haloperidol-Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 7 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Effects of discontinuation of chronic medication in primary care: a systematic review of deprescribing trials.The British journal of general practice : the journal of the Royal College of General Practitioners · 2018
    Pooled it
  5. Pharmacological interventions for apathy in Alzheimer's disease.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Guideline
  7. Pooled it
  8. The Effects ofNutrients · 2022
    Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Review
  14. Review
  15. Canadian family physician Medecin de famille canadien · 2018
    Review
  16. Review
  17. Approaches to Gradual Dose Reduction of Chronic Off-Label Antipsychotics Used for Behavioral and Psychological Symptoms of Dementia.The Consultant pharmacist : the journal of the American Society of Consultant Pharmacists · 2015
    Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

D P DevanandDivision of Geriatric Psychiatry, New York State Psychiatric Institute, College of Physicians and Surgeons, Columbia University, NY, USA. dpd3@columbia.edu
Gregory H Pelton
Karine Cunqueiro
Harold A Sackeim
Karen Marder
Columbia University · US

Funding

QUESTIONABLE DEMENTIA: COURSE AND PREDICTORS OF OUTCOMER01AG017761 · NIA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI DEVANAND, DAVANGERE P · 2000 to 2012
$7.3M
TREATMENT OF BEHAVIORAL SYMPTOMS IN ALZHEIMERS DISEASER01MH055735 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE · PI DEVANAND, DAVANGERE P · 1997 to 2001
$487k
NIA NIH HHS R01 AG017761NIA NIH HHS R01 AG17761NIMH NIH HHS R01 MH055735NIMH NIH HHS R01MH55735
6 · The paper itself

Abstract

objectiveIn patients with Alzheimer's disease (AD) with psychosis or agitation that respond to haloperidol treatment, to evaluate the risk of relapse following discontinuation.

methodsIn outpatients with AD with symptoms of psychosis or agitation, responders to 20 weeks of haloperidol (0.5-5 mg daily) were randomized to a 24-week, double-blind pilot trial of discontinuation on placebo versus continuation haloperidol. Phase A response criteria were minimum 50% reduction in three target symptoms, and improvement on the Clinical Global Impression-Change (CGI-C) score for psychosis/agitation. Phase B relapse criteria required 50% worsening in target symptoms and on the CGI-C. α = 0.1 was the significance criterion in this pilot study.

resultsOf 44 patients, 22 patients responded in Phase A. The sum score of target symptoms, and Brief Psychiatric Rating Scale (BPRS) psychosis and hostile suspiciousness factor scores, decreased in Phase A (p's < 0.001). Extrapyramidal signs increased in Phase A (p < 0.01). Of 22 responders, 21 patients entered Phase B, and 20 had at least one follow-up visit. Four of 10 patients (40%) on continuation haloperidol relapsed compared to eight of 10 patients on placebo (80%, χ(2)  = 3.3, p = 0.07). In survival analyses, time to relapse was shorter on placebo than haloperidol (χ(2)  = 4.1, p = 0.04).

conclusionsHaloperidol open treatment was efficacious, and relapse was greater on placebo than with haloperidol continuation. In patients with AD who have psychosis or agitation and respond to antipsychotic medication, the increased risk of relapse after discontinuation needs to be weighed against the side effects associated with continuing the medication.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAntipsychotic AgentsDouble-Blind MethodFemaleHaloperidolHumansMaleMiddle AgedPilot ProjectsPsychomotor AgitationPsychotic DisordersRecurrenceRiskAntipsychotic AgentsHaloperidol

Identifiers

PMID21845596
PMCPMC3685500
OpenAlexW1968770674

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.