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Osmotic-Release Oral System Methylphenidate Augmentation of Antidepressant Monotherapy in Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Trial
Abstract
Objective To evaluate the efficacy, safety, and tolerability of adjunctive osmotic-release oral system (OROS) methylphenidate in outpatients with major depressive disorder (MDD) receiving a stable oral antidepressant regimen. Method This multicenter, double-blind, randomized, placebo-controlled, parallel-group, 5-week trial enrolled 145 subjects who met DSM-IV-TR criteria for MDD and who had failed 1 to 3 previous antidepressant monotherapies (including current antidepressant) of adequate dose and duration. Augmentation therapy was initiated with 18 mg of OROS methylphenidate and increased to a maximum dose of 54 mg of OROS methylphenidate until an optimal dose was achieved. Efficacy scales included the Montgomery-Asberg Depression Rating Scale (MADRS), 7 atypical items from the 31-item Hamilton Rating Scale for Depression, the Clinical Global Impressions-Severity of Illness (CGI-S) scale, the CGI-Improvement scale (CGI-I), the Sex Effects scale, the Multidimensional Assessment of Fatigue (MAF) scale, and the Apathy Evaluation Scale (AES). Subjects were recruited at 17 community and academic centers across Canada. The study was conducted from June 8, 2005, to April 18, 2006. Results There was no statistically significant difference between the groups at endpoint on the MADRS. OROS methylphenidate was superior to placebo in improving apathy and fatigue as measured by the AES and the MAF. Statistically significant differences using mixed-model analysis were observed on the AES…
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“In support of the latter hypothesis, methylphenidate has been reported to be efficacious in reducing apathy in individuals with Alzheimer's disease (Rosenberg et al., 2013) and apathy and fatigue in individuals with MDD (Ravindran et al., 2008).”
From Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies (2016) · cites this paper as Ravindran et al., 2008
In the citing paper
“but they are generally consistent with published findings for psychostimulant (Patkar et al., 2006;Postolache et al., 1999;Ravindran et al., 2008) and modafinil augmentation studies for MDD (DeBattista et al., 2003;Dunlop et al., 2007;Fava et al., 2007) and with the conclusions of published meta-analyses (Candy et al., 2008;Fleurence et al., 2009).”
From Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies (2016) · cites this paper as Ravindran et al., 2008
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Items 101–114 of 114
The role of methylphenidate in depression
May, M. E., & VandenBerg, A. (2015) · Mental Health Clinician · doi:10.9740/mhc.2015.11.271 · Cited by 3
Depressione resistente al trattamento: stato dell’arte Parte II. Trattamento
Luchini, F., Cosentino, L., Pensabene, L., Mauri, M., & Lattanzi, L. (2014) · Rivista di psichiatria · doi:10.1708/1766.19120 · Cited by 1
Combination Therapies and Switching of Agents in Depression and Bipolar Disorders
Folsche, T., Maier, H. B., Hillemacher, T., & Frieling, H. (2021) · Springer eBooks · doi:10.1007/978-3-319-56015-1_437-1
Liu, T.-H., Huang, Y.-L., Wu, J.-Y., Lin, C., Jang, F.-L., & Lai, C.-C. (2026) · Psychological Medicine · doi:10.1017/s0033291726103845
“Most of the available evidence comes from small-sample studies or short-term randomized controlled trials, with follow-up durations typically limited to 4 – 12 weeks (Pary et al., 2015; Patkar et al., 2006; Ravindran et al., 2008).”
Chaikali, S., & Jacobsen, J. P. R. (2026) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000002180
Update on the pharmacological treatment of resistant depression
de la Barquera, J. A. O.-S. (2019) · Medicina Universitaria · doi:10.24875/rmu.19000059 · Cited by 1
The Nature and Treatment of Therapy-Resistant Depression
Kennedy, S. H., Rizvi, S. J., & Giacobbe, P. (2010) · Modern trends in psychiatry · doi:10.1159/000319516
Self-citationAdjunctive Atypical Antipsychotics in Medication-Resistant Depression
Nelson, J. C. (2010) · CNS Spectrums · doi:10.1017/s1092852900027930
BMJ Publishing Group Ltd, & Royal College of Psychiatrists and British Psychological Society (2008) · Evidence-Based Mental Health · doi:10.1136/ebmh.11.4.102 · Cited by 3
Current awareness in human psychopharmacology
(2008) · Human Psychopharmacology Clinical and Experimental · doi:10.1002/hup.891
Psychostimulants in the treatment of depressive disorders
Ekinci, O., Ekinci, A., & Bölek, S. (2014) · Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry · doi:10.5455/cap.20141201111428
Pharmacological Approaches to Treatment-Resistant Depression
D, M. F. M., & Nierenberg, A. A. (2008) · Elsevier eBooks · doi:10.1016/b978-0-323-04743-2.50046-9
Metadata
- Authors
- Ravindran, A. V., Kennedy, S. H., O'Donovan, M. C., Fallu, A., Camacho, F., & Binder, C. E.
- Affiliations
- University of Toronto (CA)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2008-01-15
- Volume
- 69
- Issue
- 1
- Pages
- 87-94
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W1987459299
- Cited by
- 119
- References
- 0
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2023: 6 · 2022: 3 · 2021: 8 · 2020: 2 · 2019: 1 · 2018: 6 · 2017: 8 · 2016: 6 · 2015: 14 · 2014: 13 · 2013: 13 · 2012: 7
- FWCI
- 5.80
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- osmotic-release oral system, OROS methylphenidate, major depressive disorder, antidepressant-resistant depression, apathy, fatigue, tolerability, adverse effects
- MeSH terms
- Adult, Central Nervous System Stimulants, Antidepressive Agents, Depressive Disorder, Major, Major Depressive Disorder, Double-Blind Method, Drug Synergism, Drug Therapy, Combination, Female, Humans, Male, Methylphenidate, Middle Aged, Severity of Illness Index, Diagnostic and Statistical Manual of Mental Disorders
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