Experimental Therapies for Treatment-Resistant Depression: "How do you decide when to go to an unproven or experimental therapy with patients that are treatment-resistant depression?"
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ABSTRACT:
SUBMITTER: Jha MK
PROVIDER: S-EPMC6103647 | biostudies-literature | 2018 Jul
REPOSITORIES: biostudies-literature
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Experimental Therapies for Treatment-Resistant Depression: "How do you decide when to go to an unproven or experimental therapy with patients that are treatment-resistant depression?"
Jha Manish K MK Trivedi Madhukar H MH
Focus (American Psychiatric Publishing) 20180718 3
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2013-03-29 | E-GEOD-45603 | biostudies-arrayexpress
Project description:Since the outbreak of COVID-19, many randomized controlled trials have been launched to test the efficacy of promising treatments. These trials will offer great promise for future treatment. However, a public health emergency calls for a balance between gathering sound evidence and granting therapeutic access to promising trial drugs as widely as possible. In an electronic survey, we found that 3.9% of the participants preferred to receive an unproven trial drug directly in the hypothetical scenario of mild COVID-19 infection. This percentage increased drastically to 31.1% and 54.2% in the hypothetical scenario of severe and extremely severe infection, respectively. Our survey indicates a likelihood of substantial receptivity of trial drugs among actual patients in severe conditions. From the perspective of deontological ethics, a trial can only be approved when potential benefits of the investigational treatment are presumed to outweigh risks, so compassionate or off-label use of investigational therapies merits evaluation.
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Project description:This study aimed to elucidate the transcriptional differences in peripheral blood mononuclear cells (PBMC) between individuals with treatment-resistant depression (TRD) and a control group without a psychiatric illness; and between patients with TRD, treated with either standard antidepressant drugs alone, or in combination with electroconvulsive therapy (ECT) or ketamine. Additionally, PBMC transcriptomics were compared between treatment responders, following completion of their treatment protocols. PBMC transcriptomics were compared between treatment responders, following completion of their treatment protocols.
2024-06-30 | GSE234669 | GEO
Project description:BackgroundTreatment-resistant depression (TRD) in major depressive disorder (MDD) is defined as the failure of two or more antidepressants. Few studies have characterized the natural history and treatment patterns of these patients. This study aims to identify the natural history of disease and treatment trajectories for patients with TRD.MethodsA retrospective longitudinal study used claims data linked to electronic health records (EHRs) from January 1, 2017, to October 31, 2021. Inclusion criteria were age ≥ 18 years, ≥ 1 MDD diagnosis, no antidepressant use at baseline, and an index date within 90 days of MDD diagnosis. Exclusions included psychiatric disorders other than MDD. TRD patients were defined as receiving third-line antidepressant treatment within two years of first-line initiation. Second- and third-line antidepressant treatment was defined as a switch to or addition of a different antidepressant with an adequate dose/duration or initiation of an augmentation treatment.ResultsOut of 301,821 individuals with MDD using antidepressants or augmentation medications during the study, 2,409 incident TRD patients were selected out of 50,374 meeting the criteria. The median time to TRD (time from first to third line index date) was 11.5 months, and the TRD episode duration was 10.8 months. Initial treatment was predominantly antidepressant monotherapy, declining from 91.0% in the first line to 39.4% in the third line. Combination therapy including antidepressants and augmentation medications increased over lines, reaching 55.6% in the third line. During the TRD episode, SSRIs were the most prescribed antidepressants with the longest duration of use. Cognitive-behavioral therapy was used by 53.5% of TRD patients, while other nonpharmacological therapies were rarely used. Treatment trajectories varied by age, sex, and anxiety.ConclusionsThis study identified contemporary treatment patterns in TRD patients, with combination therapy and augmentation medications increasingly used, highlighting the need for precision treatment based on individual trajectories.
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Project description:To further explore predictors and targets of response to infliximab, differential gene expression was examined at baseline and after 6 and 24 hours and 2 weeks after the first infusion of infliximab in TRD patients who were infliximab responders versus nonresponders, and compared to placebo-treated patients. All subjects were administered either infliximab (5mg/kg, n=30) or placebo (n=30) through an indwelling catheter at the Emory Division of Digestive Diseases at 3 separate time points (baseline, 2 weeks and 6 weeks). Infliximab infusion dosing protocol and scheduling were matched to the standard intravenous induction routine for the treatment of inflammatory bowel disease.
2013-04-01 | GSE45468 | GEO
Project description:ImportanceThere is an unmet need for effective treatments for suicidality in mental disorders. Magnetic seizure therapy (MST) has been investigated as an alternative to electroconvulsive therapy, a known effective treatment for suicidality, in the management of treatment-resistant major depressive disorder, with promising findings. Yet, there are very limited data on the association of MST with suicidality directly. It is important to explore the potential of MST as a viable treatment alternative to electroconvulsive therapy for suicidality.ObjectiveTo determine the association of MST with suicidality in patients with treatment-resistant major depressive disorder.Design, setting, and participantsThis nonrandomized controlled trial took place at a single tertiary care psychiatric facility in Canada. It followed an open-label study design with consecutive treatment cohorts. Consecutive groupings of 67 patients with treatment-resistant major depressive disorder and with baseline suicidality present were treated for up to 24 treatments. The study was run from February 2012 through June 2019. Patients were followed up for 6 months at the end of the treatment period. This post hoc secondary analysis of the trial was performed from January to November 2019.InterventionsMST was delivered at 100% stimulator output over the prefrontal cortex with low (25 Hz), moderate (50 or 60 Hz), or high (100 Hz) frequency, for a maximum of 24 sessions.Main outcomes and measuresRemission from suicidality was measured as an end point score of 0 on the Beck Scale for Suicidal Ideation. A linear mixed model was used to assess the trajectory of Beck Scale for Suicidal Ideation scores.ResultsA total of 67 patients (mean [SD] age, 46.3 [13.6] years; 40 women [60.0%]) received a mean (SD) of 19.5 (5.1) MST treatments. The overall number of patients achieving remission was 32 (47.8%). Sixteen patients (55.2%) receiving low-frequency MST achieved remission, as well as 12 patients (54.5%) in the moderate-frequency group, and 4 patients (25.0%) in the high-frequency group. The linear mixed model revealed an association of time with Beck Scale for Suicidal Ideation scores (F8,293.95 = 5.73; P < .001).Conclusions and relevanceThese findings suggest that MST may be an effective treatment for suicidality, and sensitivity analysis shows this may be particularly so at low and moderate frequencies. Future studies should directly compare MST with electroconvulsive therapy for treating suicidality and should evaluate MST as a treatment for suicidality across mental disorders.Trial registrationClinicalTrials.gov Identifier: NCT01596608.
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Project description: Not available
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Project description:To further explore predictors and targets of response to infliximab, differential gene expression was examined at baseline and after 6 and 24 hours and 2 weeks after the first infusion of infliximab in TRD patients who were infliximab responders versus nonresponders, and compared to placebo-treated patients. In a recent clinical trial, the TNF antagonist infliximab was found to reduce depressive symptoms compared to placebo but only in patients with increased inflammation as reflected by a CRP >5 mg/L. To further explore predictors and targets of response to infliximab, differential gene expression was examined at baseline and after 6 and 24 hours and 2 weeks after the first infusion of infliximab in TRD patients who were infliximab responders versus nonresponders, and compared to placebo-treated patients.
2013-04-01 | E-GEOD-45468 | biostudies-arrayexpress
Project description:BackgroundChronic and treatment-resistant depressions pose serious problems in mental health care. Mindfulness-based cognitive therapy (MBCT) is an effective treatment for remitted and currently depressed patients. It is, however, unknown whether MBCT is effective for chronic, treatment-resistant depressed patients.MethodA pragmatic, multicenter, randomized-controlled trial was conducted comparing treatment-as-usual (TAU) with MBCT + TAU in 106 chronically depressed outpatients who previously received pharmacotherapy (≥4 weeks) and psychological treatment (≥10 sessions).ResultsBased on the intention-to-treat (ITT) analysis, participants in the MBCT + TAU condition did not have significantly fewer depressive symptoms than those in the TAU condition (-3.23 [-6.99 to 0.54], d = 0.35, P = 0.09) at posttreatment. However, compared to TAU, the MBCT + TAU group reported significantly higher remission rates (χ2 (2) = 4.25, φ = 0.22, P = 0.04), lower levels of rumination (-3.85 [-7.55 to -0.15], d = 0.39, P = 0.04), a higher quality of life (4.42 [0.03-8.81], d = 0.42, P = 0.048), more mindfulness skills (11.25 [6.09-16.40], d = 0.73, P < 0.001), and more self-compassion (2.91 [1.17-4.65], d = 0.64, P = 0.001). The percentage of non-completers in the MBCT + TAU condition was relatively high (n = 12, 24.5%). Per-protocol analyses revealed that those who completed MBCT + TAU had significantly fewer depressive symptoms at posttreatment compared to participants receiving TAU (-4.24 [-8.38 to -0.11], d = 0.45, P = 0.04).ConclusionAlthough the ITT analysis did not reveal a significant reduction in depressive symptoms of MBCT + TAU over TAU, MBCT + TAU seems to have beneficial effects for chronic, treatment-resistant depressed patients in terms of remission rates, rumination, quality of life, mindfulness skills, and self-compassion. Additionally, patients who completed MBCT showed significant reductions in depressive symptoms. Reasons for non-completion should be further investigated.
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