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A Prospective Trial of Modafinil as an Adjunctive Treatment of Major Depression
Abstract
Modafinil is a wake-promoting agent approved by the Federal Drug Administration for the treatment of narcolepsy. Preliminary evidence indicates that modafinil may improve fatigue and excessive sleepiness associated with a variety of conditions. The purpose of this study was to investigate the utility of modafinil as an adjunctive treatment of depressed patients. Subjects with a history of major depression with partial response on a stable therapeutic dose of an antidepressant were eligible to participate. All subjects endorsed complaints of significant fatigue and/or excessive sleepiness on clinical assessment. Modafinil was added to their existing regimen at a dose of 100 to 400 mg/d for 4 weeks. Subjects were assessed at 2-week intervals for improvement using the standard depression scales (HDRS, BDI, CGI), fatigue scales (VASF, FSI), and a neuropsychologic battery. Thirty-five subjects were entered and 31 subjects completed the 4-week trial. Significant improvements were seen across all 3 measures of depression (HDRS, BDI, CGIS) and both measures of fatigue (VASF, FSI). On the neurocognitive battery, significant gains in the Stroop Interference Test were seen at 4 weeks, whereas the other cognitive tests showed no change. Modafinil may be a useful and a well-tolerated adjunctive agent to standard antidepressants in the treatment of major depression.
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In the citing paper
“and increase feature-based selective attention and clinical symptoms in depressed patients119.”
From Paying attention to attention in depression (2019) · cites this paper as [119]
In the citing paper
“Modafinil has only been tested as a procognitive agent for MDD in a 4-week open-label trial, enrolling 35 patients with MDD with a partial response to an antidepressant at a stable dose [147].”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [147]
In the citing paper
“However, neurocognitive function was not a primary outcome of this small, uncontrolled trial.”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [147]
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“In major depressive disorder (MDD), fatigue may be a common residual symptom because the neurotransmitter pathways implicated in the affective symptoms are not the same pathways that seem to regulate the symptoms of fatigue.”
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Bortolato, B., Miskowiak, K. W., Köhler, C. A., Maes, M., Fernandes, B. S., Berk, M., & Carvalho, A. F. (2016) · BMC Medicine · doi:10.1186/s12916-016-0560-3 · Cited by 252
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“In addition, in shortterm clinical studies, modafinil also significantly reduced fatigue and improved wakefulness in patients with multiple sclerosis,([91,92]) major depression,([93,94]) and associated neurological disorders.”
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Ersche, K. D., & Sahakian, B. J. (2007) · Neuropsychology Review · doi:10.1007/s11065-007-9033-y · Cited by 175
“Cognition-enhancing drugs such as modafinil have shown efficacy ameliorating cognitive inhibition on the Stroop task in depressed patients (DeBattista et al. 2004), enhancing cognitive flexibility on the IDED task in patients with schizophrenia (Turner et al. 2004b), and improving motor-inhibition…”
BackgroundGoss, A. J., Kaser, M., Costafreda, S. G., Sahakian, B. J., & Fu, C. H. Y. (2013) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.13r08560 · Cited by 133
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Self-citationMedical Management of Brain Tumor Patients
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“Recent studies in non-MS populations have found that stimulants such as methylphenidate [126] and modafinil [127–128] are useful adjunctive treatments for depression.”
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“Furthermore, glutamatergic agents such as Modafinil, which have been shown to prolong cocaine abstinence (Dackis et al., 2005), also have beneficial effects on both executive control and episodic memory in patients with Major Depression (DeBattista et al., 2004) and ADHD (Turner et al., 2004).”
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Carroll, J. K., Kohli, S., Mustian, K. M., Roscoe, J. A., & Morrow, G. R. (2007) · The Oncologist · doi:10.1634/theoncologist.12-s1-43 · Cited by 97
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Kaser, M., Zaman, R., & Sahakian, B. J. (2017) · Psychological Medicine · doi:10.1017/s0033291716003123 · Cited by 96
“Another noteworthy medication is modafinil which was shown to improve cognition in depression as adjunctive treatment (DeBattista et al. 2004).”
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“…working memory, have also been noted in some psychiatric groups, such as individuals with schizophrenia (Rosenthal and Bryant, 2004; Turner et al., 2004b), major depression (DeBattista et al., 2004), and attention-defi cit/hyperactivity disorder (ADHD; Greenhill et al., 2006; Turner et al., 2004a).”
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“The MGP featured modafinil in their “other reported treatments” section due to the lack of evidence supporting its use as an adjunctive treatment (Fawcett et al., 1991; DeBattista et al., 2004; Lavretsky et al., 2006; Taneja et al., 2007) and stated that other augmentation options are better supported, as the evidence…”
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“Some potentially beneficial augmentation agents that may result in cognitive benefits include psychostimulants [49,75,76], modafinil [77] and cholinesterase inhibitors [78,79].”
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“lisdexamfetamine (LDX), and nicotine (DeBattista et al., 2004; Madhoo et al., 2014; Lavretsky et al., 2015).”
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Self-citationA critical review of pharmacotherapy for major depressive disorder.
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“Case reports and controlled studies suggest that modafinil, a novel wakefulness-promoting agent, may provide benefit as an adjunctive therapy for patients with partial response or nonresponse to antidepressants.(11,12) A recent, large, placebo-controlled, double-blind, randomized trial of modafinil augmentation of SSR…”
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“…measures of attention and executive functioning in patients with attention-deficit/ hyperactivity disorder (Turner et al., 2004a), major depression (DeBattista et al., 2004), and narcolepsy (Schwartz et al., 2004; Harsh et al., 2006); and to improve depression in patients with bipolar I disorder…”
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“, 2000) uncontrolled (DeBattista et al., 2004) and placebo-controlled trials (DeBattista et al.”
BackgroundCurrent Concepts of Memory Disorder in Epilepsy: Edging Towards a Network Account
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“…[76,77], further research needs to investigate whether the alleviation of mood symptoms goes some way towards normalising the function of memory networks and memory test performances, as is seen after treatment with antidepressants like vortioxetine and modafinil in primary depression [78,79].”
Modafinil: new indications for wake promotion
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“These have included ES associated with Parkinson’s disease [56,57], myotonic dystrophy [58-60], depression [61-63], schizophrenia [64-66], traumatic brain injury [67], stroke [68], and opioid use [69], as well as fatigue in multiple sclerosis [70-72] and depression [61,62].”
BackgroundFluoxetine-Mirtazapine Interaction May Induce Restless Legs Syndrome
Prospero-Garcia, K. A., Torres-Ruiz, A., Ramírez‐Bermúdez, J., Velázquez‐Moctezuma, J., Arana-Lechuga, Y., & Terán-Pérez, G. (2006) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v67n1122d · Cited by 28
McElhiney, M. C., Rabkin, J. G., van Gorp, W. G., & Rabkin, R. (2009) · Journal of Clinical and Experimental Neuropsychology · doi:10.1080/13803390903201769 · Cited by 27
“Among patients with major depressive disorder and residual fatigue treated adjunctively with modafinil for 4 weeks, DeBattista, Lembke, Solvason, Ghebremichael, and Poirer (2004) found improvements on Stroop interference, but not on Letter–Number Sequencing, Digit Span, or Trails A, B.”
BackgroundModafinil for Atypical Depression
Vaishnavi, S., Gadde, K. M., Alamy, S., Zhang, W., Connor, K. M., & Davidson, J. R. T. (2006) · Journal of Clinical Psychopharmacology · doi:10.1097/01.jcp.0000227700.263.75.39 · Cited by 28
Manic Switch in a Patient With Treatment-Resistant Bipolar Depression Treated With Modafinil
Wolf, J., Fiedler, U., Anghelescu, I. G., & Schwertfeger, N. (2006) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v67n1122a · Cited by 27
Abbasowa, L., Kessing, L. V., & Vinberg, M. (2013) · Nordic Journal of Psychiatry · doi:10.3109/08039488.2012.752035 · Cited by 27
Conley, C. C., Kamen, C. S., Heckler, C. E., Janelsins, M. C., Morrow, G. R., Peppone, L. J., Scalzo, A. J., Gross, H. M., Dakhil, S. R., Mustian, K. M., et al. (2015) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000000442 · Cited by 26
“Randomized controlled studies have also suggested that modafinil may provide benefit as an adjunctive therapy for patients with partial response or nonresponse to typical antidepressants.(17,18) A review by Chang et al(19) found that modafinil may be an effective adjunctive treatment for depression but is most appropr…”
BackgroundHawkins, M. A. W., Dolansky, M. A., Schaefer, J. T., Fulcher, M. J., Gunstad, J., Redle, J. D., Josephson, R., & Hughes, J. W. (2014) · The Journal of Cardiovascular Nursing · doi:10.1097/jcn.0000000000000178 · Cited by 28
A Review of Psychostimulants for Adults With Depression.
Pary, R., Scarff, J. R., Jijakli, A., TOBIAS, C. R., & Lippmann, S. (2015) · Europe PMC (PubMed Central) · Cited by 24
Lam, J. Y., Freeman, M. K., & Cates, M. E. (2007) · Annals of Pharmacotherapy · doi:10.1345/aph.1h526 · Cited by 25
Sousa, A. C., & Dinis‐Oliveira, R. J. (2020) · Substance Abuse · doi:10.1080/08897077.2019.1700584 · Cited by 28
“Modafinil was shown to improve episodic memory and working memory performance in patients with remitted depression(104) and may be effective in combating the cognitive impairments often seen in major depressive disorder.(105,106) In bipolar disease, evidence suggest that modafinil may improve treatment outcomes when u…”
BackgroundSagheddu, C., Pintori, N., Kalaba, P., Dragačević, V., Piras, G., Lubec, J., Simola, N., Luca, M. A. D., Lübec, G., & Pistis, M. (2020) · Biomolecules · doi:10.3390/biom10050779 · Cited by 22
Modafinil and nicotine interactions in abstinent smokers
Sofuoglu, M., Waters, A. J., & Mooney, M. E. (2007) · Human Psychopharmacology Clinical and Experimental · doi:10.1002/hup.878 · Cited by 21
“, 2006) and to speed reaction times or reduce interference effects on Stroop tasks (DeBattista et al., 2004; Randall et al., 2004, 2005).”
BackgroundThe Black Book of Psychotropic Dosing and Monitoring
DeBattista, C., & Schatzberg, A. F. (2025) · Psychopharmacology Bulletin · doi:10.64719/pb.4493 · Cited by 23
Self-citationUltra short manic-like episodes after antidepressant augmentation with modafinil
Fountoulakis, K. Ν., Siamouli, M., Panagiotidis, P., Magiria, S., Kantartzis, S., Iacovides, A., & Kaprinis, G. (2007) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2007.11.006 · Cited by 20
Modafinil as adjunctive therapy in depressed outpatients.
Nasr, S. (2004) · Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists · doi:10.1080/10401230490486954 · Cited by 22
“Others have shown that adjunctive modafinil improves wakefulness (18), reduces fatigue (17,18,23), and enhances cognition (23) in patients with depression and a partial response to antidepressant medications.”
BackgroundContemporary methods of improving cognitive dysfunction in clinical depression
Knight, M. J., Mills, N. T., & Baune, B. T. (2019) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2019.1610395 · Cited by 17
“However, other studies have found no improvement, or improvement in only one of several measures of cognitive dysfunction, when augmenting antidepressant treatment with stimulants [83,84].”
BackgroundJoos, L., Goudriaan, A. E., Schmaal, L., van den Brink, W., Sabbe, B. G., & Dom, G. (2013) · Journal of Psychopharmacology · doi:10.1177/0269881113503505 · Cited by 19
“This may have prevented smaller treatment effects from becoming statistically significant and may explain why we did not find an effect of modafinil on our spatial planning and cognitive interference tasks, as these results are in contrast to previous studies (DeBattista et al., 2004; Randall et al., 2005; Spence et a…”
ResultRational antidepressant selection: applying evidence-based medicine to complex real-world patients.
Zetin, M., Hoepner, C. T., & Bjornson, L. (2006) · PubMed · Cited by 17
Modafinil, an atypical CNS stimulant?
Hersey, M., & Tanda, G. (2023) · Advances in pharmacology · doi:10.1016/bs.apha.2023.10.006 · Cited by 20
Tactile Hallucinations Associated With Therapeutic Doses of Bupropion in 2 Patients
Charuvastra, A., & Yaeger, D. (2006) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v67n1122e · Cited by 15
The Measurement of Fatigue in Depression
Ferentinos, P. P., Kontaxakis, V. P., Havaki-Kontaxaki, B. J., Paplos, K. G., & Soldatos, C. R. (2007) · Psychopathology · doi:10.1159/000098494 · Cited by 15
Insight into the Mechanism of Formation of Channel Hydrates via Templating
Stokes, S. P., Seaton, C. C., Eccles, K. S., Maguire, A. R., & Lawrence, S. E. (2014) · Crystal Growth & Design · doi:10.1021/cg401660h · Cited by 14
The Use of Modafinil in the Intensive Care Unit
Gajewski, M., & Weinhouse, G. L. (2015) · Journal of Intensive Care Medicine · doi:10.1177/0885066615571899 · Cited by 12
“One study of 35 patients to whose regimen of antidepressant therapy modafinil was added at a dose of 100 to 400 mg/d for 4 weeks, showed significant improvement across 3 depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory, and Clinical Global Impression Scale [CGI]) as well as on the fatigue…”
MethodPharmacological treatment approaches to difficult‐to‐treat depression
Chan, H., Mitchell, P. B., Loo, C. K. A., & Harvey, S. B. (2013) · The Medical Journal of Australia · doi:10.5694/mja12.10495 · Cited by 12
Konuk, N., Atasoy, N., Atik, L., & Akay, Ö. (2006) · Advances in Therapy · doi:10.1007/bf02850053 · Cited by 11
Post, R. M. (2005) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.6.4.531 · Cited by 11
“(2005) 6(4) refractory bipolar depression [91], although preliminary reports suggest its utility as an antifatigue agent in unipolar depression, even if the severity of depression is not affected [92,93].”
BackgroundMonoaminergic‐based Pharmacotherapy for Depression
Papakostas, G. I., & D, M. F. M. (2005) · Wiley eBooks · doi:10.1002/9783527619672.ch6 · Cited by 11
A multi-pronged investigation of option generation using depression, PET and modafinil
Ang, Y.-S., Cusin, C., Petibon, Y., Dillon, D. G., Breiger, M., Belleau, E. L., Normandin, M. D., Schroder, H. S., Boyden, S., Hayden, E. R., et al. (2021) · Brain · doi:10.1093/brain/awab429 · Cited by 10
Spreitzer, I., Keife, J., Strasser, T., Kalaba, P., Lubec, J., Neuhaus, W., Lübec, G., Langer, T., Wackerlig, J., & Loryan, I. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms242316956 · Cited by 11
Omidi-Ardali, H., Badi, A. G., Saghaei, E., & Amini-Khoei, H. (2020) · Journal of Basic and Clinical Physiology and Pharmacology · doi:10.1515/jbcpp-2020-0021 · Cited by 11
Metadata
- Authors
- DeBattista, C., Lembke, A., Solvason, H. B., Ghebremichael, R., & Poirier, J.
- Affiliations
- Stanford Medicine (US)
- Corresponding author
- DeBattista, Charles
- Venue
- Journal of Clinical Psychopharmacology
- Published
- 2004-02
- Volume
- 24
- Issue
- 1
- Pages
- 87-90
- ISSN
- 0271-0749 (ISSN-L)
- OpenAlex
- W1986635669
- Cited by
- 144
- References
- 24
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 4 · 2023: 2 · 2022: 1 · 2021: 4 · 2020: 5 · 2019: 8 · 2018: 2 · 2017: 2 · 2016: 5 · 2015: 6 · 2014: 4 · 2013: 7 · 2012: 3
- FWCI
- 12.99
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- modafinil, major depressive disorder, adjunctive therapy, fatigue, excessive sleepiness, wakefulness-promoting agents, antidepressant response, cognitive function, Stroop interference, neuropsychological assessment
- MeSH terms
- Modafinil, Adult, Aged, Antidepressive Agents, Benzhydryl Compounds, Major Depressive Disorder, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Drug Tolerance, Fatigue, Female, Humans, Disorders of Excessive Somnolence, Male, Middle Aged, Prospective Studies, Psychiatric Status Rating Scales, Time Factors, Treatment Outcome, Diagnostic and Statistical Manual of Mental Disorders
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