PROTECT: Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Sponsor

Berthold Langguth, MD, Ph.D. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05732311

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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)).

Condition or Disease	Intervention/Treatment	Phase
Depression	Device: intermittend theta burst stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: active treatment 600 pulses of iTBS per day with 120% resting motor threshold applied five days in one week; tapering interval over 8 months (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)	Device: intermittend theta burst stimulation intermittend theta burst stimulation
Active Comparator: active treatment 2 600 pulses of iTBS per day with 120% resting motor threshold applied five sessions in one day (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)	Device: intermittend theta burst stimulation intermittend theta burst stimulation

Arm

Intervention/Treatment

Experimental: active treatment

600 pulses of iTBS per day with 120% resting motor threshold applied five days in one week; tapering interval over 8 months (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)

Device: intermittend theta burst stimulation

intermittend theta burst stimulation

Active Comparator: active treatment 2

600 pulses of iTBS per day with 120% resting motor threshold applied five sessions in one day (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)

Device: intermittend theta burst stimulation

intermittend theta burst stimulation

Outcome Measures

Primary Outcome Measures

relapse (number of patients who have a relapse for depression) [33 weeks]
50% increase of symptoms according to Hamilton depression rating scale

Secondary Outcome Measures

Hamilton Depression Rating Scale [49 weeks]
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Major Depression Inventory [49 weeks]
Major Depression Inventory (range: 0-50; higher values = worse outcome)
World Health Organisation quality of life bref [49 weeks]
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
clinical global impression [49 weeks]
clinical global impression (range: 0-7; higher values = worse outcome)
Columbia-Suicide Severity Rating Scale [49 weeks]
Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)
Beck Anxiety Index [49 weeks]
Beck Anxiety Index (range: 0-63; higher values = worse outcome)
Global Assessment of Functioning [49 weeks]
Global Assessment of Functioning (range: 0-100; lower values = worse outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Berthold Langguth, MD, Ph.D.

Investigators

Principal Investigator: Berthold Langguth, Prof., University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Berthold Langguth, MD, Ph.D., Prof. Dr., University of Regensburg

ClinicalTrials.gov Identifier:

NCT05732311

Other Study ID Numbers:

22-3167-101

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Feb 22, 2023