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

Berthold Langguth, MD, Ph.D.

Status: Enrolling

Conditions: Depression

Treatments: Device: intermittend theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05732311

22-3167-101

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

active treatment

Experimental group

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)

Treatment:

Device: intermittend theta burst stimulation

active treatment 2

Active Comparator group

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)

Treatment:

Device: intermittend theta burst stimulation