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1.
Neuropsychopharmacology ; 46(2): 462-469, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32919400

RESUMO

Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.

2.
Brain Behav ; : e01805, 2020 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-33169946

RESUMO

INTRODUCTION: Treatment options are limited for patients with bipolar depression. Antidepressants added to mood stabilizers even carry risks of precipitating mixed/manic episodes. Transcranial magnetic stimulation (TMS) may provide a safe and effective option for these patients. METHODS: Database analysis of the TMS Service at Sheppard Pratt Health System identified patients with bipolar disorder type I (BD1) or II (BD2) in a pure depressive phase at initiation of TMS. Records were reviewed for response and remission rates based on MADRS scores, time to effect, and adverse events, notably treatment-emergent affective switching. All had failed at least two prior treatments for depression, were currently on at least one mood stabilizer and off antidepressants. Stimulation parameters targeted left dorsolateral prefrontal cortex: 120% motor threshold, 10 pulses per second (pps) × 4s, intertrain interval (ITI) 26s, 75 trains (37.5 min/session) for 3,000 pps total, 5 sessions/week for 30 total treatments, or until remission criteria were met. RESULTS: A total of 44 patients with BD were identified, representing 15% of the total TMS population. 77% of those who completed a course of TMS met response criteria, and 41% of subjects who completed at least 25 treatments met remission criteria. Subjects with BD1 were more likely to respond, remit, or suffer an adverse event than those with BD2. No patient met clinical criteria for a manic/mixed episode, but four (10%) discontinued due to concerns of activation. CONCLUSIONS: TMS is effective in the bipolar depressed population where episode focused intervention can be specifically offered. Risk of psychomotor agitation must be closely monitored.

3.
J Affect Disord ; 277: 65-74, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-32799106

RESUMO

BACKGROUND: Randomized clinical trials have demonstrated that Transcranial Magnetic Stimulation (TMS) is an effective treatment for episodes of major depressive disorder (MDD). However, characterization of outcomes in routine clinical practice is needed, as well as identification of patient- and treatment-related outcome predictors. This study documented patient-rated (PHQ-9) and clinician-rated (CGI-S) clinical outcomes in the NeuroStar® Advanced Therapy System Clinical Outcomes Registry. METHODS: Registry data were collected at 103 practice sites. Of 7759 participants, 5010 patients were included in an intent-to-treat (ITT) sample, defined as a primary MDD diagnosis, age ≥ 18, and completion of the PHQ-9 before TMS and with at least one PHQ-9 assessment after baseline. Completers (N = 3,814) were responders or had received ≥ 20 sessions and had an end of acute treatment PHQ-9 assessment. CGI-S ratings were obtained in smaller samples. RESULTS: In the total ITT and Completer samples, response (58-83%) and remission (28-62%) rates were notably high across self-report and clinician-administered assessments. Female patients and those treated with a larger number of pulses per session had superior clinical outcomes. LIMITATIONS: Site participation in the registry was voluntary and treatment was open label. CONCLUSIONS: The extent of clinical benefit reported by patients and clinicians following TMS in routine practice compares favorably with alternative interventions for treatment-resistant depression. Strong efficacy and the low side effect and medical risk profile suggest that TMS be evaluated as a first-line treatment for MDD. The findings derive from the largest registry of clinical outcomes in MDD for any treatment.

4.
Contemp Clin Trials ; 95: 106066, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32569757

RESUMO

Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a "coverage with evidence" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.

5.
Int J Bipolar Disord ; 8(1): 13, 2020 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-32358769

RESUMO

BACKGROUND: To compare illness characteristics, treatment history, response and durability, and suicidality scores over a 5-year period in patients with treatment-resistant bipolar depression participating in a prospective, multicenter, open-label registry and receiving Vagus Nerve Stimulation Therapy (VNS Therapy) plus treatment-as-usual (VNS + TAU) or TAU alone. METHODS: Response was defined as ≥ 50% decrease from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score at 3, 6, 9, or 12 months post-baseline. Response was retained while MADRS score remained ≥ 40% lower than baseline. Time-to-events was estimated using Kaplan-Meier (KM) analysis and compared using log-rank test. Suicidality was assessed using the MADRS Item 10 score. RESULTS: At baseline (entry into registry), the VNS + TAU group (N = 97) had more episodes of depression, psychiatric hospitalizations, lifetime suicide attempts and higher suicidality score, more severe symptoms (based on MADRS and other scales), and higher rate of prior electroconvulsive therapy than TAU group (N = 59). Lifetime use of medications was similar between the groups (a mean of 9) and was consistent with the severe treatment-resistant nature of their depression. Over 5 years, 63% (61/97) in VNS + TAU had an initial response compared with 39% (23/59) in TAU. The time-to-initial response was significantly quicker for VNS + TAU than for TAU (p < 0.03). Among responders in the first year after implant, the KM estimate of the median time-to-relapse from initial response was 15.2 vs 7.6 months for VNS + TAU compared with TAU (difference was not statistically significant). The mean reduction in suicidality score across the study visits was significantly greater in the VNS + TAU than in the TAU group (p < 0.001). CONCLUSIONS: The patients who received VNS + TAU included in this analysis had severe bipolar depression that had proved extremely difficult to treat. The TAU comparator group were similar though had slightly less severe illnesses on some measures and had less history of suicide attempts. Treatment with VNS + TAU was associated with a higher likelihood of attaining a response compared to TAU alone. VNS + TAU was also associated with a significantly greater mean reduction in suicidality. LIMITATIONS: In this registry study, participants were not randomized to the study treatment group, VNS Therapy stimulation parameters were not controlled, and there was a high attrition rate over 5 years. Trial registration ClinicalTrials.gov NCT00320372. Registered 3 May 2006, https://clinicaltrials.gov/ct2/show/NCT00320372 (retrospectively registered).

6.
J Child Adolesc Psychopharmacol ; 30(4): 261-266, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32315537

RESUMO

Objective: To describe the clinical characteristics of adolescents with antidepressant treatment-resistant major depressive disorder (MDD) and to examine the utility of the Antidepressant Treatment Record (ATR) in categorizing treatment resistance in this population. Methods: Adolescents with treatment-resistant MDD enrolled in an interventional study underwent a baseline evaluation with the ATR, Children's Depression Rating Scale-Revised (CDRS-R), and Clinical Global Impressions-Severity (CGI-S) scales. Demographic and clinical characteristics were examined with regard to ATR-defined level of resistance (level 1 to ≥3) using analysis of variance and χ2 tests. Results: In adolescents with treatment-resistant MDD (N = 97), aged 12-21 years, most were female (65%), white (89%), and had recurrent illness (78%). Patients were severely ill (median CGI-S score of 5), had a mean CDRS-R score of 63 ± 10, and 17.5% had been hospitalized for depression-related symptoms. Fifty-two patients were classified as ATR 1, whereas 32 were classified as ATR level 2 and 13 patients as ≥3, respectively. For increasing ATR-defined levels, illness duration increased from 12.0 (range: 1.5-31.9) to 14.8 (range: 1.8-31.7) to 19.5 (range: 2.5-36.2) months and the likelihood of treatment with serotonin norepinephrine reuptake inhibitors (SNRIs) and dopamine norepinephrine reuptake inhibitors (DNRIs) similarly increased (p = 0.006 for both SNRIs and DNRIs) as did the likelihood of treatment with mixed dopamine serotonin receptor antagonists (χ2 = 17, p < 0.001). Conclusions: This study underscores the morbidity and chronicity of treatment-resistant MDD in adolescents. The present characterization of related clinical features describes the use of nonselective serotonin reuptake inhibitors in adolescents with treatment-resistant depression and raises the possibility that those with the greatest medication treatment resistance are less likely to have had recurrent episodes. The study also demonstrates the utility of the ATR in categorizing treatment resistance in adolescents with MDD.

7.
Depress Anxiety ; 37(3): 261-272, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31944487

RESUMO

OBJECTIVE: Transcranial direct current stimulation (tDCS) has been found to have antidepressant effects and may have beneficial neurocognitive effects. However, prior research has produced an unclear understanding of the neurocognitive effects of repeated exposure to tDCS. The study's aim was to determine the neurocognitive effects following tDCS treatment in participants with unipolar or bipolar depression. METHOD: The study was a triple-masked, randomized, controlled clinical trial across six international academic medical centers. Participants were randomized to high dose (2.5 mA for 30 min) or low dose (0.034 mA, for 30 min) tDCS for 20 sessions over 4 weeks, followed by an optional 4 weeks of open-label high dose treatment. The tDCS anode was centered over the left dorsolateral prefrontal cortex at F3 (10/20 EEG system) and the cathode over F8. Participants completed clinical and neurocognitive assessments before and after tDCS. Genotype (BDNF Val66Met and catechol-o-methyltransferase [COMT] Val158Met polymorphisms) were explored as potential moderators of neurocognitive effects. RESULTS: The study randomized 130 participants. Across the participants, tDCS treatment (high and low dose) resulted in improvements in verbal learning and recall, selective attention, information processing speed, and working memory, which were independent of mood effects. Similar improvements were observed in the subsample of participants with bipolar disorder. There was no observed significant effect of tDCS dose. However, BDNF Val66Met and COMT Val158Met polymorphisms interacted with tDCS dose and affected verbal memory and verbal fluency outcomes, respectively. CONCLUSIONS: These findings suggest that tDCS could have positive neurocognitive effects in unipolar and bipolar depression. Thus, tDCS stimulation parameters may interact with interindividual differences in BDNF and COMT polymorphisms to affect neurocognitive outcomes, which warrants further investigation.


Assuntos
Transtorno Bipolar , Transtorno Depressivo Maior , Estimulação Transcraniana por Corrente Contínua , Transtorno Bipolar/terapia , Catecol O-Metiltransferase/genética , Método Duplo-Cego , Humanos , Córtex Pré-Frontal , Resultado do Tratamento
8.
J Psychiatr Res ; 113: 125-136, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30974339

RESUMO

There is considerable diversity in how treatment-resistant depression (TRD) is defined. However, every definition incorporates the concept that patients with TRD have not benefited sufficiently from one or more adequate trials of antidepressant treatment. This review examines the issues fundamental to the systematic evaluation of antidepressant treatment adequacy and resistance. These issues include the domains of interventions deemed effective in treatment of major depressive episodes (e.g., pharmacotherapy, brain stimulation, and psychotherapy), the subgroups of patients for whom distinct adequacy criteria are needed (e.g., bipolar vs. unipolar depression, psychotic vs. nonpsychotic depression), whether trials should be rated dichotomously as adequate or inadequate or on a potency continuum, whether combination and augmentation strategies require specific consideration, and the criteria used to evaluate the adequacy of treatment delivery (e.g., dose, duration), trial adherence, and clinical outcome. This review also presents the Antidepressant Treatment History Form: Short-Form (ATHF-SF), a completely revised version of an earlier instrument, and details how these fundamental issues were addressed in the ATHF-SF.


Assuntos
Antidepressivos/uso terapêutico , Estimulação Encefálica Profunda/métodos , Transtorno Depressivo Resistente a Tratamento/diagnóstico , Transtorno Depressivo Resistente a Tratamento/terapia , Psicoterapia/métodos , Inquéritos e Questionários , Transtorno Depressivo Resistente a Tratamento/patologia , Humanos , Resultado do Tratamento
9.
Psychiatry ; 82(1): 24-26, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30870112
10.
Neuropsychiatr Dis Treat ; 15: 457-468, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30858703

RESUMO

Objective: To compare the durations of response achieved with adjunctive vagus nerve stimulation (VNS + TAU) vs treatment as usual (TAU) alone in treatment-resistant depression (TRD) over a 5-year period in the TRD registry. Materials and methods: Data from 271 participants on TAU and 328 participants on VNS + TAU were analyzed. Response was defined as ≥50% decrease in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score at postbaseline visit and was considered retained until the decrease was <40%. MADRS was obtained quarterly in year 1 and biannually thereafter. Time-to-events were estimated using Kaplan-Meier method and compared using log-rank test. HR was estimated using Cox proportion hazard model. Results: In the VNS + TAU arm, 62.5% (205/328) of participants had a first response over 5 years compared with 39.9% (108/271) in TAU. The time to first response was significantly shorter for VNS + TAU than for TAU (P<0.01). For responders in the first year, median time to relapse from first response was 10.1 months (Q1=4.2, Q3=31.5) for VNS + TAU vs 7.3 months (Q1=3.1, Q3=17.6) for TAU (P<0.01). HR=0.6 (95% CI: 0.4, 0.9) revealed a significantly lower chance for relapse in VNS + TAU. Probability of retaining first response for a year was 0.39 (0.27, 0.51) for TAU and 0.47 (0.38, 0.56) for VNS + TAU. Timing of the onset of the response did not impact the durability of the response. Conclusion: VNS therapy added to TAU in severe TRD leads to rapid onset and higher likelihood of response, and a greater durability of the response as compared to TAU alone.

11.
Aust N Z J Psychiatry ; 53(2): 109-118, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30378447

RESUMO

OBJECTIVES: The report considers the pros and cons of the most commonly used conceptual model that forms the basis for most clinical practice guidelines for depression. This model promotes the attainment of sustained symptom remission as the treatment goal based on its well-established prognostic and functional importance. Sustained remission is very unlikely, however, after multiple treatment attempts. Our current model propels many clinicians to continue to change or add treatments despite little chance for remission or full functional restoration and despite the increasing risk of more adverse events from polypharmacy. An alternative 'difficult-to-treat depression' model is presented and considered. It accepts that the treatment aims for some depressed patients may shift to optimal symptom control rather than remission. When difficult-to-treat depression is suspected, the many treatable causes of persistent depression must be assessed and addressed (given the importance of remission when attainable) before difficult-to-treat depression can be ascribed. The clinical and research implications of the difficult-to-treat depression model are discussed. CONCLUSION: Suspected difficult-to-treat depression provides a practical basis for considering when to conduct a comprehensive evaluation. Once difficult-to-treat depression is confirmed, treatment may better focus on optimal disease management (symptom control and functional improvement).


Assuntos
Transtorno Depressivo Resistente a Tratamento , Gerenciamento Clínico , Humanos , Modelos Psicológicos
12.
Brain Stimul ; 11(6): 1282-1290, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30172724

RESUMO

BACKGROUND: Transcranial direct current stimulation (tDCS) has promising antidepressant effects, however, clinical trials have shown variable efficacy. Pre-treatment neurocognitive functioning has previously been identified as an inter-individual predictor of tDCS antidepressant efficacy. OBJECTIVE: In this international multicentre, sham-controlled study, we investigated this relationship while also assessing the influence of clinical and genotype (BDNF Val66Met and COMT Val158Met polymorphisms) factors as predictors of response to active tDCS. METHODS: The study was a triple-masked, parallel, randomized, controlled design across 6 international academic medical centers. Participants were randomized to active (2.5 mA) or sham (34 µA) tDCS for 30 min each session for 20 sessions. The anode was centered over the left dorsolateral prefrontal cortex at F3 (10/20 EEG system) and the cathode over the lateral right frontal area at F8. RESULTS: Better pre-treatment attentional processing speed on the Ruff 2 & 7 Selective Attention Test (Total Speed: ß = 0.25, p < .05) and concurrent antidepressant medication use (ß = 0.31, p < .05) predicted antidepressant efficacy with active tDCS. Genotype differences in the BDNF Val66Metand COMT Val158Met polymorphisms were not associated with antidepressant effects. Secondary analyses revealed that only participants in the highest performing Ruff 2 & 7 Total Speed group at pre-treatment in both active and sham tDCS conditions showed significantly greater antidepressant response compared to those with lower performance at both the 2 and 4 week treatment time points (p < .05). CONCLUSIONS: These results suggest that high pre-treatment attentional processing speed may be relevant for identifying participants more likely to show better tDCS antidepressant response to both high (2.5 mA) and very low (34 µA) current intensity stimulation. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov, NCT01562184.


Assuntos
Atenção/fisiologia , Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Maior/terapia , Internacionalidade , Estimulação Transcraniana por Corrente Contínua/métodos , Adulto , Transtorno Depressivo Maior/diagnóstico , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Córtex Pré-Frontal/fisiologia , Resultado do Tratamento
13.
Psychiatr Clin North Am ; 41(3): 409-418, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30098654

RESUMO

Vagus nerve stimulation (VNS) has been studied for its effect on treatment-resistant depression. Open-label studies have shown a significant positive effect in an especially treatment-resistant depressive population. Insurance company support for VNS has been limited but may be reviewed given recent positive open-label data. Coming developments in novel external ways to stimulate the vagus nerve may revive interest in this area. This article reviews the clinical development of VNS starting with the first recognition of its potential for treating depression, parses the results of several large clinical trials, and suggests a future path for optimal clinical development and use.


Assuntos
Ensaios Clínicos como Assunto , Transtorno Depressivo Maior/terapia , Transtorno Depressivo Resistente a Tratamento/terapia , Avaliação de Resultados em Cuidados de Saúde , Estimulação do Nervo Vago/métodos , Humanos , Estimulação do Nervo Vago/efeitos adversos , Estimulação do Nervo Vago/instrumentação
15.
J Clin Psychiatry ; 79(5)2018 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-30152645

RESUMO

OBJECTIVE: To compare quality-of-life (QOL) change associated with treatment as usual (TAU, any antidepressant treatment) versus adjunctive vagus nerve stimulation treatment (VNS + TAU) in a population of patients with treatment-resistant depression (TRD) for 5 years. METHODS: Self-reported QOL assessments, using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), were gathered in a multicenter, longitudinal registry (January 2006-May 2015) comparing the antidepressant efficacy of VNS + TAU versus TAU in TRD. All depressed patients (N = 599), with either unipolar or bipolar depression, met DSM-IV-TR major depressive episode criteria and failed at least 4 adequate antidepressant trials. The Montgomery-Asberg Depression Rating Scale (MADRS) was administered by blinded raters. Q-LES-Q-SF scores in the treatment arms were compared via linear regression; linear regression was employed to compare QOL differences with percent decrease in MADRS. A subanalysis comparing Q-LES-Q-SF functional domain change was performed. RESULTS: 328 VNS + TAU and 271 TAU patients with TRD were compared. On average, VNS + TAU demonstrated a significant, comparative QOL advantage over TAU (as demonstrated via non-overlapping 95% confidence bands) that began at 3 months and was sustained through 5 years and was reinforced using a clinical global improvement measure. Patients receiving VNS + TAU, but not TAU alone, demonstrated a clinically meaningful QOL improvement (34% MADRS decrease) well below the classically defined antidepressant response (50% MADRS decrease). Exploratory post hoc subanalysis demonstrated that VNS + TAU had a significant advantage in multiple Q-LES-Q domains. CONCLUSION: Compared to TAU, adjunctive VNS significantly improved QOL in TRD, and this QOL advantage was sustained. Further, TRD patients treated with VNS experienced clinically meaningful QOL improvements even with depression symptom reduction less than the conventional 50% reduction used to ascribe "response."


Assuntos
Transtorno Depressivo Maior/terapia , Transtorno Depressivo Resistente a Tratamento/terapia , Qualidade de Vida , Estimulação do Nervo Vago/métodos , Antidepressivos/uso terapêutico , Terapia Combinada/métodos , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Resultado do Tratamento
16.
J ECT ; 34(4): 258-265, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29613944

RESUMO

BACKGROUND: Neurocognitive dysfunction is an understudied and undertreated aspect of psychiatric research and treatment. There is emerging evidence to suggest that repetitive transcranial magnetic stimulation (rTMS) may possess neurocognition-enhancing capabilities. METHODS: This study examined the neurocognitive data from a randomized, double-blind, sham-controlled trial of an investigational 2-coil rTMS device in antidepressant treatment or treatment-intolerant major depressive disorder patients. This device has the potential to stimulate deeper areas of the brain than the Food and Drug Administration-approved TMS devices, which primarily stimulate cortical brain areas and may therefore have different neurocognitive adverse effects. Patients received 20 daily rTMS treatments (10-Hz stimulation; either active or sham) with coil centers positioned over the left dorsolateral prefrontal cortex and dorsomedial prefrontal cortex. Neurocognitive safety was evaluated at baseline and within 72 hours of final treatment session with a computerized battery assessing aspects of attention and memory in 84 participants. RESULTS: There were no observed negative neurocognitive effects of the 2-coil rTMS device. A significant effect of active rTMS was observed on the quality of episodic memory. There were no observed effects for attention or working memory. Baseline quality of episodic memory predicted depression treatment response and remission, in that lower baseline episodic memory was associated with greater likelihood of depression response/remission. This was observed in logistic regression analyses controlling for treatment and baseline depressive symptoms. CONCLUSIONS: The 2-coil rTMS device is a cognitively safe treatment for treatment-resistant depression that may possess episodic memory-enhancing capabilities. Furthermore, baseline episodic memory may reflect an important predictor of subsequent depression treatment response/remission to rTMS.


Assuntos
Cognição , Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Maior/terapia , Transtorno Depressivo Resistente a Tratamento/terapia , Estimulação Magnética Transcraniana/métodos , Adolescente , Adulto , Idoso , Transtorno Depressivo Resistente a Tratamento/psicologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Memória , Pessoa de Meia-Idade , Testes Neuropsicológicos , Córtex Pré-Frontal , Estudos Prospectivos , Escalas de Graduação Psiquiátrica , Estimulação Magnética Transcraniana/instrumentação , Resultado do Tratamento , Adulto Jovem
18.
Brain Stimul ; 10(5): 926-933, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28642024

RESUMO

BACKGROUND: Therapeutic repetitive Transcranial Magnetic Stimulation (rTMS) has emerged as a standard of care for individuals with major depressive disorder (MDD) who do not benefit from, or are unable to tolerate, antidepressant pharmacotherapy. Depth of stimulation is limited with currently approved figure-eight coils and larger coils capable of deeper penetration may be associated with loss of stimulation focality and undesired recruitment of motor cortex. A second generation 2-coil array rTMS system was designed to target converging brain pathways for potentially deeper prefrontal cortex stimulation. METHODS: A randomized, double-blind, sham-controlled trial examined the safety and efficacy of an investigational 2-coil rTMS device. Antidepressant treatment-resistant or treatment-intolerant MDD patients (n = 92) received 20 daily rTMS treatments with coil centers positioned over left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC). 10 Hz stimulation (maximum summated power for both coils ≤ 120% motor threshold) was delivered. Primary efficacy endpoint was change in HAMD-24 score from baseline to the conclusion of treatments. RESULTS: Data from n = 75 (per-protocol sample) showed significantly greater improvement (mean HAMD-24 change) over time for the active (n = 38) versus sham (n = 37) group after 20 sessions (F = 7.174; p = 0.008) and also at the one-month follow-up (F = 6.748; p = 0.010). Response rates were 55.3% (active) versus 32.4% (sham) (p = 0.063); remission rates were 26.3% versus 18.9% (p > 0.05). Other secondary outcomes were generally supportive. CONCLUSIONS: The results confirmed safety and acute efficacy of the 2-coil rTMS device. Despite modest sample size, primary outcome was clinically and statistically significant, and the effect size was comparable with those reported for regulatory trials with FDA-cleared devices.


Assuntos
Transtorno Depressivo Resistente a Tratamento/fisiopatologia , Transtorno Depressivo Resistente a Tratamento/terapia , Estimulação Magnética Transcraniana/métodos , Adulto , Transtorno Depressivo Resistente a Tratamento/diagnóstico , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Córtex Motor/fisiopatologia , Córtex Pré-Frontal/fisiologia , Estudos Prospectivos , Estimulação Magnética Transcraniana/efeitos adversos , Resultado do Tratamento
19.
Am J Psychiatry ; 174(7): 640-648, 2017 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-28359201

RESUMO

OBJECTIVE: The Treatment-Resistant Depression Registry investigated whether adjunctive vagus nerve stimulation (VNS) with treatment as usual in depression has superior long-term outcomes compared with treatment as usual only. METHOD: This 5-year, prospective, open-label, nonrandomized, observational registry study was conducted at 61 U.S. sites and included 795 patients who were experiencing a major depressive episode (unipolar or bipolar depression) of at least 2 years' duration or had three or more depressive episodes (including the current episode), and who had failed four or more depression treatments (including ECT). Patients with a history of psychosis or rapid-cycling bipolar disorder were excluded. The primary efficacy measure was response rate, defined as a decrease of ≥50% in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score at any postbaseline visit during the 5-year study. Secondary efficacy measures included remission. RESULTS: Patients had chronic moderate to severe depression at baseline (the mean MADRS score was 29.3 [SD=6.9] for the treatment-as-usual group and 33.1 [SD=7.0] for the adjunctive VNS group). The registry results indicate that the adjunctive VNS group had better clinical outcomes than the treatment-as-usual group, including a significantly higher 5-year cumulative response rate (67.6% compared with 40.9%) and a significantly higher remission rate (cumulative first-time remitters, 43.3% compared with 25.7%). A subanalysis demonstrated that among patients with a history of response to ECT, those in the adjunctive VNS group had a significantly higher 5-year cumulative response rate than those in the treatment-as-usual group (71.3% compared with 56.9%). A similar significant response differential was observed among ECT nonresponders (59.6% compared with 34.1%). CONCLUSIONS: This registry represents the longest and largest naturalistic study of efficacy outcomes in treatment-resistant depression, and it provides additional evidence that adjunctive VNS has enhanced antidepressant effects compared with treatment as usual in this severely ill patient population.


Assuntos
Transtorno Bipolar/terapia , Transtorno Depressivo Maior/terapia , Transtorno Depressivo Resistente a Tratamento/terapia , Ideação Suicida , Estimulação do Nervo Vago/métodos , Adulto , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/psicologia , Doença Crônica , Transtorno Depressivo Maior/diagnóstico , Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Resistente a Tratamento/diagnóstico , Transtorno Depressivo Resistente a Tratamento/psicologia , Eletroconvulsoterapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Resultado do Tratamento
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