Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: intermittend theta burst stimulation (iTBS)

• Registration Number: NCT05732298
• Lead Sponsor: University of Regensburg

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-17
• Study Start: 2023-02-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active treatment	intermittend theta burst stimulation (iTBS)	intermittent theta burst stimulation

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	8 weeks	Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy; 🇩🇪 Regensburg, Germany