Who is sponsoring NCT04123301?

NCT04123301 is sponsored by University of Sao Paulo.

What drugs are being tested in NCT04123301?

Interventions in NCT04123301: Active Theta Burst Stimulation (TBS), Sham Theta Burst Stimulation (TBS).

What condition does NCT04123301 study?

NCT04123301 studies Depressive Episode, Depressive Disorder, Bipolar Disorder.

Is NCT04123301 still recruiting?

NCT04123301 is currently status unknown. Last updated 10 October 2019.

Last reviewed 2019-10-10 · How we verify

NCT04123301

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Theta-Burst Stimulation in Major Depressive Episodes With Mixed Characteristics.

Status unknown NA Last updated 10 October 2019

What this trial tests

NA trial testing Active Theta Burst Stimulation (TBS) in Depressive Episode in 90 participants. Status unknown.

Timeline

8 March 2019

Primary endpoint
1 March 2021

1 May 2021

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	8 March 2019
Primary completion	1 March 2021
Estimated completion	1 May 2021
Sites	1 location across Brazil

Drugs / interventions tested

Active Theta Burst Stimulation (TBS)
Sham Theta Burst Stimulation (TBS)

Conditions studied

Depressive Episode — all drugs for Depressive Episode →
Depressive Disorder — all drugs for Depressive Disorder →
Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 65, any sex, with Depressive Episode or Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators will perform a double-blind, randomized, sham-controlled clinical trial of theta-burst stimulation (TBS) in mixed depressive episodes of both bipolar and major depressive disorders. Will be selected 90 patients aged 18-65 years with diagnosis of TB (I or II) or MDD in moderate or severe major depressive episode with mixed features. The primary endpoint of efficacy will be a continuous outcome of change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 3.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial.
Tavares DF, Suen P, Rodrigues Dos Santos CG, Moreno DH, et al · · 2021 · cited 17× · PMID 34193961 · DOI 10.1038/s41386-021-01080-9
Distractibility, anxiety, irritability, and agitation symptoms are associated with the severity of depressive and manic symptoms in mixed depression.
Tavares DF, Suen P, Moreno DH, Vieta E, et al · · 2022 · cited 3× · PMID 36580584 · DOI 10.47626/1516-4446-2022-2606
Efficacy, Safety, and Tolerability of Theta-Burst Stimulation in Mixed Depression: Design, Rationale, and Objectives of a Randomized, Double-Blinded, Sham-Controlled Trial.
Tavares DF, Dos Santos CGR, Valiengo LDCL, Klein I, et al · · 2020 · cited 3× · PMID 32499730 · DOI 10.3389/fpsyt.2020.00435

Verify or expand the search:

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Currently open trials in the same condition.

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Other University of Sao Paulo trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04123301 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
Last refreshed: 10 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04123301.

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