Coadministration of Modafinil and a Selective Serotonin Reuptake Inhibitor From the Initiation of Treatment of Major Depressive Disorder With Fatigue and Sleepiness

Dunlop, Boadie W.; Crits‐Christoph, Paul; Evans, Dwight L.; Hirschowitz, Jack; Solvason, H. Brent; Rickels, Karl; Garlow, Steven J.; Gallop, Robert; Ninan, Philip T.

doi:10.1097/jcp.0b013e31815abefb

Cited by 49 publications

(33 citation statements)

References 25 publications

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“…[8] Most guidelines have suggested that nonresponders or partial responders should be considered for switch, combination or augmentation treatment. [9][10][11][12] Traditional augmentation agents such as lithium, triiodothyronine (T3), buspirone, [13] azapirone, [14] dopamine agonists (including pramipexole and ropinirole), [15,16] modafinil [17][18][19][20][21][22][23] and stimulants (including methylphenidate) [12,24] have been commonly used for this patient population, but with limited supporting data. Recently, augmentation of antidepressant therapy with atypical antipsychotics has become a more commonly accepted treatment practice.…”

Section: Introductionmentioning

confidence: 99%

Aripiprazole as Adjunctive Therapy for Patients with Major Depressive Disorder

2011

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Aripiprazole was initially approved to treat schizophrenia and later approved for bipolar mania, as a monotherapy and an adjunctive therapy (manic or mixed episodes), and for irritability associated with autism. Aripiprazole is a partial agonist at dopamine D(2) and D(3) and serotonin 5-HT(1A) receptors, and is an antagonist at 5-HT(2A) receptors. This profile, and convincing preliminary data from small-scale studies, provided the rationale for the large-scale exploration of aripiprazole for unipolar depression. Recently, three 6-week, large-scale, randomized, double-blind, placebo-controlled clinical trials demonstrated clinically meaningful efficacy for aripiprazole as an adjunctive therapy to antidepressants for treating major depressive disorder (MDD). In November 2007, aripiprazole was approved by the US FDA as an adjunctive therapy to antidepressants for treating MDD, with support from two of the above-mentioned trials. In the trials, aripiprazole was demonstrated to be safe and well tolerated, and showed a minimal trend for weight gain over the course of a 6-week treatment. The incidence of akathisia was higher than that reported in studies of patients with schizophrenia; however, most cases were mild to moderate and infrequently lead to discontinuation (5/1090 from all three trials). This comprehensive review provides an overview of the data from all three 6-week studies (including a pooled analysis) and from an unpublished 52-week, open-label extension study, to inform physicians and facilitate reasonable treatment decisions. In addition, specific issues associated with the use of aripiprazole as an adjunctive therapy in patients with MDD, including possible early treatment effect, appropriate timing of therapy initiation, appropriate dosing and duration of treatment, possible differential effect on depressive subgroups and long-term tolerability, are also discussed.

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Section: Introductionmentioning

confidence: 99%

Aripiprazole as Adjunctive Therapy for Patients with Major Depressive Disorder

2011

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“…Modafinil, a newer stimulant which has been proposed to have a mechanism of action independent of its effects on dopamine, has been investigated as an augmenting agent in two large, placebo-controlled trials. Initial improvement in depressive symptoms seen with modafinil was not sustained, although apathy and fatigue remained significantly improved from baseline 92 93. A subsequent retrospective pooled analysis suggested that modafinil augmentation may improve depression in TRD patients with significant sleepiness and fatigue 92…”

Section: Pharmacotherapy For Trdmentioning

confidence: 97%

Pharmacologic approaches to treatment resistant depression: a re-examination for the modern era

Philip

Carpenter

Tyrka

et al. 2010

Expert Opinion on Pharmacotherapy

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Importance of the field Treatment-resistant depression (TRD) is common and debilitating. Initial treatment is often insufficient to achieve full remission in a given depressive episode, resulting in more frequent episodes, worsened severity, and major disability. Areas covered in this review This review surveys literature on the diagnosis and pharmacological management of TRD in light of recent developments. Evidence regarding commonly used treatment options is critically examined and key recommendations are offered. The review ends by considering drugs acting on the melatonin, acetylcholine, and glutamate systems that hold promise as future options for TRD. What the reader will gain Recent trends and research findings have impacted how the evidence supporting different approaches to TRD should be evaluated. For example, many earlier TRD studies employed tricyclics (TCAs) as the primary antidepressant, but TCAs have now been superseded by selective serotonin reuptake inhibitors (SSRIs) in routine clinical practice. This deficiency has been addressed by the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, the largest effectiveness study of TRD ever conducted. However, design characteristics of the STAR*D study preclude simple comparisons with earlier studies. Take home message A shortcoming of most treatment recommendations for TRD is their reliance on older studies that do not reflect the current preeminence of SSRIs in clinical practice. This has distorted the prioritization of pharmacological strategies for TRD. Efforts to correct this distortion with effectiveness research, designed to better reflect current practice trends, require critical consideration of the strengths and limitations of this approach.

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“…Two large randomized controlled trials of lisdexamfetamine in the treatment of MDD in SSRI non-remitters revealed no efficacy of the psychostimulant (Shrie, 2014). A double blind, placebo-controlled study assessed adjunctive modafinil or placebo (to an SSRI) and found that modafinil did not have any benefit (Dunlop et al, 2007). A Cochrane review published in 2008 included 13 trials for metaanalysis.…”

Section: Stimulant Augmentationmentioning

confidence: 98%