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Theta-Burst Stimulation efficacy, safety, and tolerability in mixed depressive episodesof bipolar and major depressive disorders.

Abstract

The DSM-5 introduced the mixed characteristics specifier that can be applied to depressive or hypo (manic) episodes of both patients with bipolar disorder (type I or II) as well as major depressive disorder (MDD). Mood disorders with mixed specifiers are probably a different subgroup in terms of clinical response to treatment, socio-demographic parameters, course (frequency of recurrences, predominant polarity, etc.) and family history. The main objective of this study is to provide recommendations about safety, tolerability and efficacy of treatment of moderate to severe major depressive episodes with mixed characteristics resistant to pharmacological treatment with TBS magnetic stimulation in type I TB, type II TB and TDM. We will perform a 6-week, randomized, double-blind, parallel group, 6-week, parallel-group clinical trial comprising 5x / week (Monday to Friday) in the first 3 weeks and then 2x / week At least 1 day between sessions) for another 3 weeks of actual or simulated TBS. 90 adult patients, aged between 18 and 65 years, with a diagnosis of type I TB, type II TB or MDD in a moderate or severe major depressive episode with mixed characteristics will be selected. The primary endpoint of effectiveness will be improvement of at least 25% on the depression (MADRS) AND mania scale (YOUNG) from baseline to week 3 of stimulation (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
TAVARES, DIEGO FREITAS; SUEN, PAULO; RODRIGUES DOS SANTOS, CARLA GARCIA; MORENO, DORIS HUPFELD; LANE VALIENGO, LEANDRO DA COSTA; KLEIN, IZIO; BORRIONE, LUCAS; MARQUES FORTE, PAMELA; BRUNONI, ANDRE R.; ALBERTO MORENO, RICARDO. Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial. NEUROPSYCHOPHARMACOLOGY, v. 46, n. 13, p. 2257-2265, DEC 2021. Web of Science Citations: 0.
TAVARES, DIEGO FREITAS; SUEN, PAULO; RODRIGUES DOS SANTOS, CARLA GARCIA; MORENO, DORIS HUPFELD; LANE VALIENGO, LEANDRO DA COSTA; KLEIN, IZIO; BORRIONE, LUCAS; MARQUES FORTE, PAMELA; BRUNONI, ANDRE R.; ALBERTO MORENO, RICARDO. Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial. NEUROPSYCHOPHARMACOLOGY, JUN 2021. Web of Science Citations: 0.
TAVARES, DIEGO FREITAS; RODRIGUES DOS SANTOS, CARLA GARCIA; LANE VALIENGO, LEANDRO DA COSTA; KLEIN, IZIO; BORRIONE, LUCAS; FORTE, PAMELA MARQUES; BRUNONI, ANDRE R.; MORENO, RICARDO ALBERTO. Efficacy, Safety, and Tolerability of Theta-Burst Stimulation in Mixed Depression: Design, Rationale, and Objectives of a Randomized, Double-Blinded, Sham-Controlled Trial. FRONTIERS IN PSYCHIATRY, v. 11, MAY 15 2020. Web of Science Citations: 0.

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