Psychostimulants are commonly added to antidepressants in order to augment their effects, but most of the clinical trials have been either open or small controlled trials. In what may be the largest trial done to date, these investigators (who received funding from Janssen-Ortho, the maker of Concerta) randomized 145 depressed patients, all of whom had failed at least one trial of an antidepressant, to either Concerta augmentation (n = 73) or placebo augmentation (n = 72). Concerta was started at 18 mg/day and was gradually increased, as needed, up to a maximum of 54 mg/day; the average final dose was 36.4 mg/day. The primary outcome measure was the MADRS depression scale score after 5 weeks. Results: There was no difference between Concerta and placebo on the MADRS scale, nor on any of the secondary outcome scales except for the Apathy Evaluation Scale, which showed a small improvement in favor of Concerta. Concerta also outperformed placebo on measures of fatigue early on, but at the 5 week endpoint, there was no significant benefit (Ravindran AV et al., J Clin Psychiatry 2008;69:87-94).
TCPR’s Take: Similar to earlier placebo- controlled trials of Provigil augmentation, it appears that Concerta augmentation doesn’t have an effect on the core symptoms of depression, but is somewhat helpful for apathy and fatigue. Whether this benefit is sufficient to outweigh the disadvantages of prescribing a stimulant (mild increase in heart rate and blood pressure, the hassles of prescribing a scheduled substance) is a judgement call for each clinician and each patient.
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