Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

Depression Clinical Trial

— TRUST  

Official title:

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732298
• Other study ID #: 22-3053-101
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2023
• Source: University of Regensburg
• Contact: Martin Schecklmann, Prof.
• Phone: +49-941-941-1256
• Email: martin.schecklmann[@]medbo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS).

This is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks).

The patients to be treated are those who refuse treatment with antidepressant medications.

The effectiveness of the four-week iTBS treatment is to be evaluated in comparison to a "watchful waiting" after 4 weeks.

A interim analysis is planned after 36 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• uni- or bipolar depression according to ICD-10

• present episode at least four weeks

• 18-70 years old

• no intake and rejection of anti-depressant medication and

• no adequate anti-depressant medication in the present episode

• no or stable non-drug anti-depressant treatment (e.g. psychotherapy)

• residency in Germany, German speaking

Exclusion Criteria:

• contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker

• relevant neurological or internistic diseases according to study investigator

• participation in other trials during treatment

• pregnancy or breatfeeding

• legal care and placement in a psychiatric hospital

• active suicidality

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• intermittend theta burst stimulation (iTBS)
600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale	Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)	8 weeks
Secondary	Hamilton Depression Rating Scale	Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)	20 weeks
Secondary	Major Depression Inventory	Major Depression Inventory (range: 0-50; higher values = worse outcome)	20 weeks
Secondary	World Health Organisation quality of life bref	World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)	20 weeks
Secondary	State Trait Anxiety Inventory	State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome)	20 weeks
Secondary	clinical global impression	clinical global impression (range: 0-7; higher values = worse outcome)	20 weeks