Evidence map›Paper›PMID 21777715›Full record

Trial reportPsychosomatics

Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.

Judith G Rabkin, Martin C McElhiney, Richard Rabkin

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Psychosomatics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00737204 (Armodafinil Treatment for Fatigue in HIV+ Patients), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 19% 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.

NCT00737204 phase4completednot on this map

Armodafinil Treatment for Fatigue in HIV+ Patients

TypeinterventionalSponsorNew York State Psychiatric InstituteRan2008 to 2010Enrolled70ConditionsHIV Infections, FatigueArmsArmodafinil, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pharmacological treatments for fatigue associated with palliative care.The Cochrane database of systematic reviews · 2015
    Pooled it
  2. Trial
  3. A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015
    Trial
  4. Effect of armodafinil on cognition in patients with HIV/AIDS and fatigue.Journal of clinical and experimental neuropsychology · 2013
    Trial
  5. Article
  6. Review
  7. Article
  8. Fatigue in HIV-Infected People: A Three-Year Observational Study.Journal of pain and symptom management · 2015
    Observational
  9. 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

3 authors at 1 institution in 1 country.

Judith G RabkinNew York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons, Columbia University, 1051 Riverside Drive, New York, NY 10032, USA. jgr1@columbia.edu
Martin C McElhiney
Richard Rabkin
Columbia University · US

Funding

The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI MILTON L WAINBERG · 2003 to 2026
$48.2M
Modafinil Treatment for Fatigue in HIV+ PatientsR01MH072383 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI RABKIN, JUDITH G. · 2005 to 2008
$1.3M
NIMH NIH HHS P30 MH043520NIMH NIH HHS R01 MH072383
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess its effect on depressive symptoms and behavior once fatigue remitted.

methodHIV+ patients with clinically significant fatigue were treated in a placebo-controlled randomized double-blind trial for 4 weeks. Armodafinil responders and placebo non-responders or relapsers were treated openly for a total of 16 weeks with armodafinil. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement Scale, supplemented by the Fatigue Severity Scale, the Hamilton Depression Rating Scale, and the Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV RNA viral load and the SAFTEE side effects rating scale. Maximum trial dose of armodafinil was 250 mg/d.

resultsSeventy patients were enrolled. Attrition was 9%. In intention-to-treat analyses, fatigue response rate to armodafinil was 75% and to placebo, 26%. Armodafinil did not reduce depressive symptoms in the absence of improved energy, but of those patients with an Axis I depressive disorder at study entry whose energy improved, 82% experienced improved mood as well. Markers of immunologic suppression did not change during treatment. At 6 months, those still taking armodafinil had more energy and fewer depressive symptoms than those who were no longer taking it.

conclusionsAs we found in our RCT of modafinil, armodafinil appears effective and well tolerated in treating fatigue in HIV+ patients. Side effects were minimal and most patients reported substantially improved energy and mood.

Indexed as

AdultAgedBenzhydryl CompoundsCD4 Lymphocyte CountCentral Nervous System StimulantsDepressionDouble-Blind MethodFatigueFemaleHIV InfectionsHumansMaleMiddle AgedModafinilNeuropsychological TestsPsychiatric Status Rating ScalesBenzhydryl CompoundsCentral Nervous System StimulantsModafinil

Identifiers

PMID21777715
PMCPMC3142348
OpenAlexW2078303486

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.