Evidence map›Paper›PMID 29924506›Full record

Trial reportThe Journal of clinical psychiatry2018

Clinical Predictors of Extrapyramidal Symptoms Associated With Aripiprazole Augmentation for the Treatment of Late-Life Depression in a Randomized Controlled Trial.

Jonathan H Hsu, Benoit H Mulsant, Eric J Lenze, Marcos Sanches, Jordan F Karp, Charles F Reynolds, Daniel M Blumberger

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00892047 (Incomplete Response in Late Life Depression), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 46% 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.

NCT00892047 phase4completednot on this map

Incomplete Response in Late Life Depression: Getting to Remission

TypeinterventionalSponsorUniversity of PittsburghRan2009 to 2014Enrolled468ConditionsDepressionArmsvenlafaxine XR plus aripiprazole, venlafaxine plus placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pharmacological interventions for treatment-resistant depression in adults.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Article
  3. Review
  4. Article
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

7 authors at 4 institutions in 2 countries.

Jonathan H HsuCampbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Benoit H MulsantCampbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Eric J LenzeHealthy Mind Laboratory, Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.
Marcos SanchesCampbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Jordan F KarpDepartment of Psychiatry, Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Charles F ReynoldsDepartment of Psychiatry, Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Daniel M BlumbergerLate-Life Mood Disorders Clinic, Centre for Addiction and Mental Health, 1001 Queen St W, Unit 4, Room 115, Toronto, ON M6J 1H4. daniel.blumberger@camh.ca.
Centre for Addiction and Mental Health · CAPublic Health Ontario · CAUniversity of Toronto · CAVA Pittsburgh Healthcare System · US

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
RESEARCH METHODS COREP30MH090333 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI DEW, MARY AMANDA · 2011 to 2015
$8.3M
1/3-Incomplete Response in Late-Life Depression: Getting to RemissionR01MH083660 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REYNOLDS, CHARLES F. · 2009 to 2013
$2.7M
2/3-Incomplete Response in Late-Life Depression: Getting to RemissionR01MH083648 · NIMH · WASHINGTON UNIVERSITY · PI LENZE, ERIC J · 2009 to 2013
$2.0M
3/3-Incomplete Response in Late-Life Depression: Getting to RemissionR01MH083643 · NIMH · CENTRE FOR ADDICTION AND MENTAL HEALTH · PI MULSANT, BENOIT H · 2009 to 2013
$1.3M
3/3 Buprenorphine for Late-Life Treatment Resistant DepressionR34MH101365 · NIMH · CENTRE FOR ADDICTION AND MENTAL HEALTH · PI BLUMBERGER, DANIEL M. · 2014 to 2016
$479k
NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR002345NIMH NIH HHS P30 MH090333NIMH NIH HHS R01 MH083643NIMH NIH HHS R01 MH083648NIMH NIH HHS R01 MH083660NIMH NIH HHS R34 MH101365
6 · The paper itself

Abstract

objectiveAugmentation with aripiprazole is an effective pharmacotherapy for treatment-resistant late-life depression (LLD). However, aripiprazole can cause extrapyramidal symptoms (EPS) such as akathisia and parkinsonism; these symptoms are distressing and can contribute to treatment discontinuation. We investigated the clinical trajectories and predictors of akathisia and parkinsonism in older patients receiving aripiprazole augmentation for treatment-resistant LLD.

methodsBetween 2009 and 2013, depressed older adults who did not remit with venlafaxine were randomized to aripiprazole or placebo in a 12-week trial. Participants were 60 years or older and met DSM-IV-TR criteria for major depressive episode with at least moderate symptoms. The presence of akathisia and parkinsonism was measured at each visit using the Barnes Akathisia Scale (BAS) and Simpson-Angus Scale (SAS), respectively. In an exploratory analysis, we examined a broad set of potential clinical predictors and correlates: age, sex, ethnicity, weight, medical comorbidity, baseline anxiety severity, depression severity, concomitant medications including rescue medications, and aripiprazole dosage.

resultsTwenty-four (26.7%) of 90 participants randomized to aripiprazole and who had akathisia scores available developed akathisia compared to 11 (12.2%) of 90 randomized to placebo. Greater depression severity was the main predictor of treatment-emergent akathisia. Most participants who developed akathisia improved over time, especially with reductions in dosage. Fifteen (16.5%) of 91 participants taking aripiprazole and who had parkinsonism scores available developed parkinsonism, but no clinical predictors or correlates were identified.

conclusionsAkathisia is a common side effect of aripiprazole, but it is typically mild and responds to dose reduction. Patients with greater baseline depression may warrant closer monitoring for akathisia. More research is needed to understand the course and predictors of treatment-emergent EPS with antipsychotic augmentation for treatment-resistant LLD.

trial registrationClinicalTrials.gov identifier: NCT00892047.

Indexed as

AgedAkathisia, Drug-InducedAntidepressive AgentsAripiprazoleDepressive Disorder, Treatment-ResistantFemaleHumansLate Onset DisordersMaleParkinson Disease, SecondaryRisk FactorsTime FactorsAntidepressive AgentsAripiprazole

Identifiers

PMID29924506
PMCPMC6996023
OpenAlexW2809074711

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.