Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report

Rush, A. John; Trivedi, Madhukar H.; Wisniewski, Stephen R.; Nierenberg, Andrew A.; Stewart, Jonathan W.; Warden, M.B.A. Diane; Niederehe, George; Thase, Michael E.; Lavori, Philip W.; Lebowitz, Barry D.; McGrath, Patrick J.; Rosenbaum, Jerrold F.; Sackeïm, Harold A.; Kupfer, David J.; Luther, James F.; Fava, Maurizio

doi:10.1176/ajp.2006.163.11.1905

Cited by 4,254 publications

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“…This compares with a < 15% remission rate in the STAR*D study for subsequent antidepressant treatment in patients who had experienced two or more prospective treatment failures. 4 A recent UK RCT in patients with a similar degree of treatment resistance as in the patients in this study (mean MGHS score of 4.7), although with a lesser severity of depression (baseline mean MADRS score of 28), reported a 21% response rate and a 16% remission rate after 5 weeks in patients treated with placebo or metyrapone DISCUSSION NIHR Journals Library www.journalslibrary.nihr.ac.uk augmentation of ongoing antidepressant treatment. 162 This suggests that patients in this study received considerable clinical benefit attributable to ECT treatment.…”

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confidence: 54%

“…The Quick Inventory of Depressive Symptomatology -Self Report (QIDS-SR) 142 is a 16-item self-rated depression scale that was used in the STAR*D study 4 and rates the nine DSM-IV depression items, each on a scale of 0-3.…”

Section: Quick Inventory Of Depressive Symptomatology -Self Reportmentioning

confidence: 99%

“…had recovered or had minimal symptoms) after the first antidepressant and this fell to about one in seven in patients who had failed two or more treatments; overall, about one-third of patients failed to remit even after four sequential pharmacological treatments. 4 …”

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Randomised controlled trial of ketamine augmentation of electroconvulsive therapy to improve neuropsychological and clinical outcomes in depression (Ketamine-ECT study)

et al. 2017

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BackgroundElectroconvulsive therapy (ECT) is the most effective acute treatment for severe depression, but there are concerns about its adverse cognitive effects. ECT may impair cognition through stimulation of glutamate receptors, and preliminary evidence has suggested that ketamine, a glutamate antagonist, may alleviate these effects. Ketamine has been shown to have a rapid, but temporary, antidepressant effect after a single infusion.ObjectiveTo determine the efficacy and safety of adjunctive low-dose ketamine to reduce cognitive impairments caused by ECT and, secondarily, to improve symptomatic outcome.DesignMulticentre, two-arm, parallel-group, patient-randomised, placebo-controlled superiority trial.SettingEleven ECT suites based in seven NHS trusts in the north of England.ParticipantsSeverely depressed hospitalised patients or outpatients who received ECT as part of their usual clinical care.InterventionsPatients were randomised to ketamine (0.5 mg/kg) or saline as an adjunct to their anaesthetic for their ECT course in a 1 : 1 ratio.Main outcome measuresThe primary outcome was delayed verbal recall on the Hopkins Verbal Learning Task – Revised (HVLT-R) after four ECT treatments (mid-ECT), analysed using a Gaussian repeated measures model. Secondary outcomes included autobiographical, working and visual memory and verbal fluency, symptoms and quality of life; assessments occurred at mid-ECT, end of treatment and 1 and 4 months after the last ECT. Neuropsychological function was compared with that of healthy control subjects and a functional near-infrared spectroscopy (fNIRS) substudy investigated prefrontal cortex function. A patient survey of study participation was carried out.ResultsSeventy-nine severely depressed patients were randomised to ketamine (0.5 mg/kg) or saline as an adjunct to their anaesthetic for their ECT course; the modified intention-to-treat sample included 70 patients. Compared with saline, adjunctive ketamine had no significant effect on HVLT-R delayed recall [treatment effect difference –0.43, 95% confidence interval (CI) –1.73 to 0.87], other neuropsychological outcomes, improvement in depression [difference in Montgomery–Åsberg Depression Rating Scale (MADRS) score of 0.44, 95% CI –1.03 to 1.91], the number of ECT treatments to remission (MADRS score of ≤ 10: 0.83, 95% CI –3.2 to 4.9), anxiety symptoms or quality of life. By the end of ECT treatment, 37% (saline 35%, ketamine 39%) of patients had remitted. Tolerability was similar in the two treatment arms; two patients had isolated transient psychological effects attributable to ketamine. Preliminary fNIRS analysis found that patients had blunted prefrontal cortical haemodynamic responses compared with control subjects during a verbal fluency task at baseline; this was further diminished at mid-ECT without modulation by ketamine. Greater haemodynamic responsivity to ECT appeared to be associated with a better clinical response. The majority of patients surveyed reported a positive experience of study participation.ConclusionsThe results of the study do not support the use of adjunctive ketamine in routine ECT treatment in the NHS. Although no evidence of benefit was found for ketamine, moderate benefits or harms cannot be excluded, as recruitment was < 50% of that planned, limiting the power of the clinical trial. Low numbers also meant that in the fNIRS substudy the effect of ketamine could not be assessed and the other findings must be viewed as preliminary. Included patients were younger than those not included and had only limited cognitive impairment with ECT, limiting generalisation to more cognitively compromised patients. fNIRS appeared to be a potentially feasible portable brain imaging technology in severely ill patients and further research is warranted to investigate its clinical utility.Trial registrationCurrent Controlled Trials ISRCTN14689382.FundingThis project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership.

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confidence: 54%

Section: Quick Inventory Of Depressive Symptomatology -Self Reportmentioning

confidence: 99%

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Randomised controlled trial of ketamine augmentation of electroconvulsive therapy to improve neuropsychological and clinical outcomes in depression (Ketamine-ECT study)

et al. 2017

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“…Due to the high prevalence of resistance to treatment and failed antidepressant response, the National Institute of Mental Health developed the Sequenced Treatment Alternatives to Relieve Depression Trial, a systematic protocol for treating depression. According to the latter protocol, cumulative response and remission rates after two unsuccessful antidepressant treatments are 73% and 47% respectively 23 . Based on these data, numerous repetitive TMS (rTMS) studies have been performed on the treatment of major depressive disorder and have shown positive results, suggesting that low-frequency stimulation (1Hz) of the right dorsolateral prefrontal cortex, or high frequency over the left dorsolateral prefrontal cortex, both have antidepressant effects 24 .…”

Section: Noninvasive Transcranial Stimulation For Major Depressive DImentioning

confidence: 99%

Transcranial magnetic stimulation and transcranial direct current stimulation appear to be safe neuromodulatory techniques useful in the treatment of anxiety disorders and other neuropsychiatric disorders

Iannone

Cruz

Brasil‐Neto

et al. 2016

Arq. Neuro-Psiquiatr.

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Transcranial magnetic stimulation (TMS) has recently been investigated as a possible adjuvant treatment for many neuropsychiatric disorders, and has already been approved for the treatment of drug-resistant depression in the United States and in Brazil, among other countries. Although its use in other neuropsychiatric disorders is still largely experimental, many physicians have been using it as an off-label add-on therapy for various disorders. More recently, another technique, transcranial direct current stimulation (tDCS), has also become available as a much cheaper and portable alternative to TMS, although its mechanisms of action are different from those of TMS. The use of off-label therapeutic TMS or tDCS tends to occur in the setting of diseases that are notoriously resistant to other treatment modalities. Here we discuss the case of anxiety disorders, namely panic and post-traumatic stress disorders, highlighting the uncertainties and potential problems and benefits of the clinical use of these neuromodulatory techniques at the current stage of knowledge.

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“…This important finding highlights that the aim of treatment must be full and complete symptom resolution (symptom remission) rather than response or removal of most of the symptoms, not only to reduce the risk of relapse 4 but also to enhance recovery. This finding also aligns with other studies that have shown remission to be associated with a far better prognosis than is response without remission.…”

mentioning

confidence: 97%

Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report

Cited by 4,254 publications

References 50 publications

Randomised controlled trial of ketamine augmentation of electroconvulsive therapy to improve neuropsychological and clinical outcomes in depression (Ketamine-ECT study)

Randomised controlled trial of ketamine augmentation of electroconvulsive therapy to improve neuropsychological and clinical outcomes in depression (Ketamine-ECT study)

Transcranial magnetic stimulation and transcranial direct current stimulation appear to be safe neuromodulatory techniques useful in the treatment of anxiety disorders and other neuropsychiatric disorders

Distinguishing Functional From Syndromal Recovery: Implications for Clinical Care and Research

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