NCT03953521

Brief Summary

In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex. Randomisation will be balanced for in- and out-patients and for the treatment arms.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 14, 2019

Last Update Submit

May 28, 2020

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • HAMD

    Hamilton Depression Rating Scale

    4 weeks

Secondary Outcomes (5)

  • HAMD

    16 weeks

  • MDI

    16 weeks

  • PHQ-9

    16 weeks

  • WHOQOL-BREF

    16 weeks

  • CGI

    16 weeks

Study Arms (2)

navigated

EXPERIMENTAL

Positioning of the coil according to neuronavigation (Mylius et al., 2013, Definition of DLPFC and M1 according to anatomical landmarks for navigated brain stimulation: Inter-rater reliability, accuracy, and influence of gender and Age, NeuroImage 78, 224-232).

Device: intermittent Theta burst stimulation

F3

ACTIVE COMPARATOR

Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap).

Device: intermittent Theta burst stimulation

Interventions

intermittent Theta burst stimulationDEVICE

Stimulation of the left dorsolateral prefrontal Cortex with a specific repetitive transcranial magnetic Stimulation protocol (intermittent Theta burst Stimulation) according to Blumberger et al., 2018, Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692.

F3navigated

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unipolar or bipoloar depressive Episode according to ICD-10
  • at least moderate Depression according to Hamilton Depression Rating Scale or ICD-10
  • if applicable stable medication with psychoactive compounds for out-patients
  • if applicable no or stable Treatment for Depression during the course of the Trial
  • residence in Germany and mother tongue German
  • written informed consent

You may not qualify if:

  • Meeting the contraindications for transcranial magnetic Stimulation or magnetic resonance Imaging (electic devices or metal implants in the Body, e.g. cardiac pace maker, Insulin ppump)
  • neurological disorders (e.g. cerebrovascular Events, neurodegenerative disorder, epilepsy, brain malformation, severe head Trauma)
  • addictive disorder with consumption in the last two years
  • regular intake of benzodiazepines
  • participation in another study parallel to the Trial
  • pregnancy or breastfeading period
  • psychiatric confinement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

Location

Related Publications (1)

  • Hebel T, Gollnitz A, Schoisswohl S, Weber FC, Abdelnaim M, Wetter TC, Rupprecht R, Langguth B, Schecklmann M. A direct comparison of neuronavigated and non-neuronavigated intermittent theta burst stimulation in the treatment of depression. Brain Stimul. 2021 Mar-Apr;14(2):335-343. doi: 10.1016/j.brs.2021.01.013. Epub 2021 Jan 22.

    PMID: 33493624DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Berthold Langguth, PhD

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

June 1, 2019

Primary Completion

May 27, 2020

Study Completion

May 27, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

DE(1)