Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Depression Clinical Trial

— PROTECT  

Official title:

Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732311
• Other study ID #: 22-3167-101
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: University of Regensburg
• Contact: Martin Schecklmann, Prof.
• Phone: +49-941-941-2054
• Email: martin.schecklmann[@]medbo.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
• moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 >16 points)
• response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment <11 points)
• no concomitant psychotic symptoms.
• no other relevant psychiatric disorder as assessed by the study physician
• residence in Germany and German speaking that allows understanding of the information provided
• patient is capable of giving consent

Exclusion Criteria:

• fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps).
• severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
• current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
• acute suicidality
• pregnancy
• current participation in another study

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• intermittend theta burst stimulation
intermittend theta burst stimulation

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Berthold Langguth, MD, Ph.D.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse (number of patients who have a relapse for depression)	50% increase of symptoms according to Hamilton depression rating scale	33 weeks
Secondary	Hamilton Depression Rating Scale	Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)	49 weeks
Secondary	Major Depression Inventory	Major Depression Inventory (range: 0-50; higher values = worse outcome)	49 weeks
Secondary	World Health Organisation quality of life bref	World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)	49 weeks
Secondary	clinical global impression	clinical global impression (range: 0-7; higher values = worse outcome)	49 weeks
Secondary	Columbia-Suicide Severity Rating Scale	Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)	49 weeks
Secondary	Beck Anxiety Index	Beck Anxiety Index (range: 0-63; higher values = worse outcome)	49 weeks
Secondary	Global Assessment of Functioning	Global Assessment of Functioning (range: 0-100; lower values = worse outcome)	49 weeks