Trial reportThe Journal of clinical psychiatry2010
Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study.
Trial report in The Journal of clinical psychiatry, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled 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.
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.
Modafinil Treatment for Fatigue in HIV+ Patients
Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Pharmacological treatments for fatigue associated with palliative care.The Cochrane database of systematic reviews · 2015Pooled it
- Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.Sleep medicine · 2016Trial
- Predictors of depression recovery in HIV-infected individuals managed through measurement-based care in infectious disease clinics.Journal of affective disorders · 2016Trial
- The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial.Neuro-oncology · 2013Trial
- Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.PsychosomaticsTrial
- Examining the Long-Term Sequelae of SARS-CoV2 Infection in Patients Seen in an Outpatient Psychiatric Department.Neuropsychiatric disease and treatment · 2022Article
- Dopaminergic impact of cART and anti-depressants on HIV neuropathogenesis in older adults.Brain research · 2019Review
- Neuropsychiatric Aspects of Infectious Diseases: An Update.Critical care clinics · 2017Review
- Neurobehavioral Manifestations of Human Immunodeficiency Virus/AIDS: Diagnosis and Treatment.Neurologic clinics · 2016Review
- Fatigue in HIV-Infected People: A Three-Year Observational Study.Journal of pain and symptom management · 2015Observational
- Modafinil #259.Journal of palliative medicine · 2012Article
- A 7-item version of the fatigue severity scale has better psychometric properties among HIV-infected adults: an application of a Rasch model.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2011Article
- Safety considerations in drug treatment of depression in HIV-positive patients: an updated review.Drug safety · 2011Review
- Clinical, laboratory, and neuroimaging characteristics of fatigue in HIV-infected individuals.Journal of neurovirology · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo evaluate the efficacy and safety of modafinil in the treatment of fatigue in patients with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and to assess effect on depressive symptoms.
methodPatients who were HIV+ and had clinically significant fatigue (according to the Fatigue Severity Scale [FSS]) were included in a 4-week randomized, placebo-controlled, double-blind trial. This was followed by an additional 8 weeks of open-label treatment for modafinil responders and 12 weeks for placebo nonresponders. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement scale, supplemented by the FSS, Hamilton Depression Rating Scale, and Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV ribonucleic acid (RNA) viral load. Visits were weekly for 4 weeks, then biweekly, with a follow-up visit at 6 months. Maximum trial dose of modafinil was 200 mg/d. Data for this study were collected between December 2004 and December 2008.
results115 patients were randomly assigned. In intention-to-treat analyses, fatigue response rate to modafinil was 73% and to placebo, 28%. Attrition was 9%. Modafinil did not have an effect on mood alone in the absence of improved energy. At week 4, CD4 cell counts did not change significantly; HIV RNA viral load showed a trend decline for patients taking modafinil but not for those taking placebo. At 6 months, those still taking modafinil had more energy and fewer depressive symptoms than patients who were not taking modafinil, and only those still taking modafinil showed a significant decline from baseline in their HIV RNA viral load.
conclusionsModafinil appears to be effective and well tolerated in treating fatigue in HIV+ patients. Consideration of its use is warranted considering the high prevalence of fatigue in the HIV community, its minimal side effects, and overall patient acceptance.
trial registrationclinicaltrials.gov Identifier: NCT00118378.
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What OpenQuestion holds
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.