A Randomized, Double-blind, Placebo-controlled Trial of Augmentation With an Extended Release Formulation of Methylphenidate in Outpatients With Treatment-Resistant Depression
Abstract
We examined the efficacy and tolerability of augmentation with an extended release formulation of methylphenidate (OROS MPH, Concerta) in patients with major depression who were nonresponders or partial responders to antidepressants. Sixty subjects with treatment-resistant depression (TRD) participated in a 4-week, randomized, double-blind, placebo-controlled study of augmentation with methylphenidate (18-54 mg/d). The preexisting antidepressant dose was unchanged. The primary efficacy measure was change in the 21-item Hamilton Depression Rating Scale from randomization to end of treatment. Data were analyzed with intent-to-treat with last observation carried forward approach. There were no statistically significant differences between the methylphenidate (n = 30) and placebo (n = 30) groups in reduction in 21-item Hamilton Depression Rating Scale scores (drug, -6.9; placebo, -4.7) from baseline to end of treatment (F1,47 = 1.24, P = 0.22), although responders were numerically higher in the extended-release methylphenidate group (40.0%) than in the placebo group (23.3%). On the secondary efficacy measures of changes in Clinical Global Impression-Improvement and Severity scores and Beck Depression Inventory-Second Edition, the drug failed to separate from placebo, although the proportion of responders in the drug group were numerically higher than placebo. There were no significant differences in weight, heart rate, and blood pressure changes between the 2 groups. The common adverse events were loss of appetite, nausea, headache, and anxiety. The mean dose of drug was 34.2 mg/d. The study did not demonstrate a statistically significant benefit for augmentation with methylphenidate in TRD. Combination of methylphenidate with antidepressants was well tolerated. Adequately powered, randomized, controlled trials are necessary to fully evaluate the efficacy of extended-release methylphenidate in TRD.
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A randomized, double-blind, placebo-controlled trial of augmentation with methylphenidate in individuals with treatment-resistant depression did not find a statistically significant improvement in individuals receiving the stimulant versus placebo.
“One randomized, double-blind, placebo-controlled trial of augmentation with methylphenidate in individuals with treatmentresistant depression did not find a statistically significant improvement in individuals receiving the stimulant versus placebo [136].”
From Adult ADHD and comorbid disorders: clinical implications of a dimensional approach (2017) · cites this paper as [136]
These findings are generally consistent with published findings for psychostimulant and modafinil augmentation studies for MDD and with the conclusions of published meta-analyses.
“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).”
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- Authors
- Patkar, A. A., Masand, P. S., Pae, C.-U., Peindl, K., Hooper-Wood, C., Mannelli, P., & Ciccone, P.
- Affiliations
- Duke University (US)
- Duke Medical Center (US)
- Corresponding author
- Patkar, Ashwin A.
- Masand, Prakash S.
- Pae, Chi-Un
- Peindl, Kathleen
- Mannelli, Paolo
- Venue
- Journal of Clinical Psychopharmacology
- Published
- 2006-12
- Volume
- 26
- Issue
- 6
- Pages
- 653-656
- ISSN
- 0271-0749 (ISSN-L)
- OpenAlex
- W2051933342
- Cited by
- 140
- References
- 11
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 3 · 2023: 4 · 2022: 9 · 2021: 5 · 2020: 2 · 2019: 1 · 2018: 3 · 2017: 7 · 2016: 7 · 2015: 14 · 2014: 7 · 2013: 11 · 2012: 6
- FWCI
- 8.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- treatment-resistant depression, methylphenidate, sustained-release formulation, antidepressant augmentation, major depressive disorder, drug efficacy, tolerability, adverse events
- MeSH terms
- Adolescent, Adult, Aged, Central Nervous System Stimulants, Antidepressive Agents, Delayed-Action Preparations, Depressive Disorder, Major, Major Depressive Disorder, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Methylphenidate, Middle Aged, Psychiatric Status Rating Scales, Time Factors, Treatment Outcome, Treatment Failure, Diagnostic and Statistical Manual of Mental Disorders
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