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


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.

Psychiatry Res ; 205(1-2): 67-73, 2013 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-23021320


As they alleviate major depressive disorder, antidepressant therapies may improve associated sleep disturbances, but may also have inherent sedating or activating properties. We examined sleep changes during a multicenter, sham-controlled, trial of transcranial magnetic stimulation (TMS) therapy for pharmacoresistant MDD. Medication-free outpatients (N=301) were randomized to receive active (N=155) or sham (N=146) TMS for 6 weeks. Depression severity was rated with the Montgomery-Asberg Depression Rating Scale, the 24-item Hamilton Depression Scale (HAMD), and the Inventory of Depressive Symptoms-Self Report (IDS-SR). Assessments were performed at baseline, 2, 4, and 6 week time points. Sleep was assessed using the HAMD and IDS-SR sleep factors; comparison between treatment groups employed ANCOVA model. No significant differences were identified between the active and sham treatment groups in either the HAMD or IDS-SR sleep factor scores at any time during treatment. Sleep difficulty as an adverse event over the length of the study did not differ between active and sham treatment. Stratified by end of acute treatment responder status, there was a statistically significant improvement in both the HAMD sleep factor score and the IDS-SR sleep factor during acute treatment in both the active and sham treatment conditions. TMS exerts no intrinsic effect upon sleep in patients with MDD.

Transtorno Depressivo Maior/terapia , Córtex Pré-Frontal , Transtornos do Sono-Vigília/etiologia , Sono/fisiologia , Estimulação Magnética Transcraniana/efeitos adversos , Adulto , Transtorno Depressivo Maior/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
J Clin Psychiatry ; 69(2): 222-32, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18232722


BACKGROUND: Transcranial magnetic stimulation (TMS) has demonstrated efficacy in the treatment of major depressive disorder; however, prior studies have provided only partial safety information. We examined the acute efficacy of TMS in a randomized sham-controlled trial, under open-label conditions, and its durability of benefit. METHOD: Aggregate safety data were obtained from a comprehensive clinical development program examining the use of TMS in the treatment of major depressive disorder. There were 3 separate clinical protocols, including 325 patients from 23 clinical sites in the United States, Australia, and Canada. Active enrollment occurred between January 2004 and August 2005. Adverse events were assessed at each study visit by review of spontaneous reports with separate reporting of serious adverse events. Safety assessments were also completed for cognitive function and auditory threshold. Assessment of disease-specific risk included the potential for worsening of depressive symptoms. Finally, the time course and accommodation to the most commonly appearing adverse events were considered. RESULTS: TMS was administered in over 10,000 cumulative treatment sessions in the study program. There were no deaths or seizures. Most adverse events were mild to moderate in intensity. Transient headaches and scalp discomfort were the most common adverse events. Auditory threshold and cognitive function did not change. There was a low discontinuation rate (4.5%) due to adverse events during acute treatment. CONCLUSIONS: TMS was associated with a low incidence of adverse events that were mild to moderate in intensity and demonstrated a largely predictable time course of resolution. TMS may offer clinicians a novel, well-tolerated alternative for the treatment of major depressive disorder that can be safely administered in an outpatient setting. TRIAL REGISTRATION: Identifier: NCT00104611.

Transtorno Depressivo Maior/terapia , Estimulação Magnética Transcraniana , Adulto , Idoso , Limiar Auditivo , Austrália , Canadá , Cognição , Transtorno Depressivo Maior/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Retratamento , Segurança , Índice de Gravidade de Doença , Estimulação Magnética Transcraniana/efeitos adversos , Estimulação Magnética Transcraniana/métodos , Resultado do Tratamento , Estados Unidos