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Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression (PROTECT)

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intermittend theta burst stimulation
Sponsored by
Berthold Langguth, MD, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of RegensburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

active treatment

active treatment 2

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2023
Last Updated
April 25, 2023
Sponsor
Berthold Langguth, MD, Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05732311
Brief Title
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Acronym
PROTECT
Official Title
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Berthold Langguth, MD, Ph.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)). For purposes of effect size estimation an interim analysis will be done after half of the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active treatment
Arm Type
Experimental
Arm Description
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)
Arm Title
active treatment 2
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
intermittend theta burst stimulation
Intervention Description
intermittend theta burst stimulation
Primary Outcome Measure Information:
Title
relapse (number of patients who have a relapse for depression)
Description
50% increase of symptoms according to Hamilton depression rating scale
Time Frame
33 weeks
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Time Frame
49 weeks
Title
Major Depression Inventory
Description
Major Depression Inventory (range: 0-50; higher values = worse outcome)
Time Frame
49 weeks
Title
World Health Organisation quality of life bref
Description
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Time Frame
49 weeks
Title
clinical global impression
Description
clinical global impression (range: 0-7; higher values = worse outcome)
Time Frame
49 weeks
Title
Columbia-Suicide Severity Rating Scale
Description
Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)
Time Frame
49 weeks
Title
Beck Anxiety Index
Description
Beck Anxiety Index (range: 0-63; higher values = worse outcome)
Time Frame
49 weeks
Title
Global Assessment of Functioning
Description
Global Assessment of Functioning (range: 0-100; lower values = worse outcome)
Time Frame
49 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Schecklmann, Prof.
Phone
+49-941-941-2054
Email
martin.schecklmann@medbo.de
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdelnaim, Dr.
Phone
+49-941-941-1256
Email
mohamed.abdelnaim@medbo.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, Prof.
Organizational Affiliation
University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
ZIP/Postal Code
93055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Phone
+49-941-941-2099
Email
berthold.langguth@medbo.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

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