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Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBerthold Langguth, MD, Ph.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • intermittend theta burst stimulation

    Device

    intermittend theta burst stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: active treatmentExperimental treatment 1 intervention
Group B: active treatment 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

relapse (number of patients who have a relapse for depression)

50% increase of symptoms according to Hamilton depression rating scale

Time frame
33 weeks

Secondary outcomes

1

Hamilton Depression Rating Scale

Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)

Time frame
49 weeks
2

Major Depression Inventory

Major Depression Inventory (range: 0-50; higher values = worse outcome)

Time frame
49 weeks
3

World Health Organisation quality of life bref

World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)

Time frame
49 weeks
4

clinical global impression

clinical global impression (range: 0-7; higher values = worse outcome)

Time frame
49 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Berthold Langguth, MD, Ph.D.

Lead sponsor

University of Regensburg

Sponsor institution

Source ClinicalTrials.gov
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