Restoring function in major depressive disorder: A systematic review

Sheehan, David V.; Nakagome, Kazuyuki; Asami, Yuko; Pappadopulos, Elizabeth; Boucher, Matthieu

doi:10.1016/j.jad.2017.02.029

Cited by 119 publications

(93 citation statements)

References 97 publications

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“…42 In a systematic review of studies that assessed functional outcomes, the authors suggested that improvements in function (SDS) should be considered for inclusion as co-endpoints with symptomatic assessments when evaluating treatments for MDD. 43 Routine assessments of both symptoms and function could be helpful for minimizing residual effects that increase the risk for relapse or recurrence. 43 Pimavanserin was well tolerated in this study.…”

Section: Discussionmentioning

confidence: 99%

“…43 Routine assessments of both symptoms and function could be helpful for minimizing residual effects that increase the risk for relapse or recurrence. 43 Pimavanserin was well tolerated in this study. The AE profile was consistent with those of previous studies of pimavanserin for Parkinson's disease psychosis and Alzheimer's disease psychosis, 44,45 and discontinuations for AEs were lower with pimavanserin than with placebo.…”

Section: Discussionmentioning

confidence: 99%

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY)

Fava¹,

Dirks²,

Freeman³

et al. 2019

J. Clin. Psychiatry

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Objective: Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD). Methods: This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score. Results: Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was −1.7 (0.85) (P = .039) and for the SDS score was −0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (−4.0 [1.09], P = .0003) and SDS (−1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache. Conclusions: Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience. Trial Registration: ClinicalTrials.gov identifier: NCT03018340 J Clin Psychiatry 2019;80(6):19m12928 To cite: Fava M, Dirks B, Freeman MP, et al. A phase 2, randomized, doubleblind, placebo-controlled study of adjunctive pimavanserin in patients with major depressive disorder and an inadequate response to therapy (CLARITY).

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY)

Fava¹,

Dirks²,

Freeman³

et al. 2019

J. Clin. Psychiatry

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“…Treatment response is measured by improvement in depressive symptoms, but functional improvement often lags behind symptomatic improvement. Functional impairment contributes to significant disability in MDD . SASS might also have appropriately recognized residual depressive symptoms related to driving impairment in past studies .…”

Section: Discussionmentioning

confidence: 99%

“…Functional impairment contributes to significant disability in MDD. 52 SASS might also have appropriately recognized residual depressive symptoms related to driving impairment in past studies. 12,32 Favorable social function is thought of as not the only factor but as one of the factors determining driving ability.…”

Section: Factors Affecting Driving Performance In Patients With Deprementioning

confidence: 99%

Driving performance of stable outpatients with depression undergoing real‐world treatment

Miyata

Iwamoto

Kawano

et al. 2018

Psychiatry Clin Neurosci

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“…Depression contributes to significant economic burden and is associated with comorbid diseases (i.e. cardiovascular disease), and impaired health-related quality of life and functioning (1)(2)(3)(4)(5). Despite advances in the treatment of depression, one-third of depressed patients fail to respond to conventional antidepressant medication (6).…”

Section: Introductionmentioning

confidence: 99%

Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial

Naumann

Sadaghiani

Kruza

et al. 2018

Preprint

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Background: Evaluation of efficacy, safety and feasibility of hyperthermic baths (HTB;head-out-of-water-immersion in 40°C), twice a week, compared to a physical exercise program (PEP; moderate intensity aerobic exercises) in moderate to severe depression. Method: Single-site, open-label randomized controlled 8-week parallel-group pilot study at an university outpatient clinic as part of usual depression care. Medically stable outpatients with depressive disorder (ICD-10: F32/F33) as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥18 and a score ≥2 on item 1 (Depressed Mood) were randomly assigned to receive either two sessions of HTB or PEP per week (40-45 min) provided by two trained doctoral students. An independent biometric center used computer-generated tables to allocate treatments. Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) principle.Findings: 45 patients (HTB n = 22; PEP n = 23) were randomized and analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference was 4.3 points in the HAM-D score in favor of HTB (p<0.001). This improvement was achieved after two weeks. Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was far higher than in other trials investigating exercise in depression (18.1 % dropouts).Conclusions: HTB seems to be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depressive disorder after two weeks; it is also suitable for persons who have problems performing exercise training. Trial registration: German Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

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Restoring function in major depressive disorder: A systematic review

Cited by 119 publications

References 97 publications

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY)

Driving performance of stable outpatients with depression undergoing real‐world treatment

Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial

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