Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve Patients With Major Depression

NCT04000022 | Unknown FDA Device

• 1 other identifier: NAIV
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) has become a safe and efficacious treatment for patients with treatment-resistant depression. In several studies investigating the antidepressant efficacy of rTMS, it has been shown that in low treatment-resistant patients rTMS is more efficacious than in patients where several treatment attempts have failed. Albeit this finding, most studies to date primarily recruited patients with relatively high degrees of treatment-resistance and there is a lack of trials investigating rTMS as a first-line treatment. Therefore, this trials aims to compare the antidepressant efficacy of 4 weeks open-label theta-burst TMS in non-treatment-resistant patients with a comparable group of treatment-resistant MDD patients.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; rTMS; TBS; Theta Burst Stimulation; Neuronavigation; Non-Treatment Resistant; Pharmaco-Naïve

Outcome Measures

Primary Outcomes (1)

• Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS-17) over 7 timepoints

  Remission defined as HDRS-17 score (range: 0 to 52) of less than or equal to 8 after the iTBS course. Response defined as a reduction of at least 50% from baseline in HDRS-17 score after treatment

  Six weekly measurements starting 1 week before first iTBS treatment session, one follow-up measurement four weeks after last measurement

Study Arms (2)

Non-Treatment Resistant Patients

Device: intermittent theta burst stimulation (iTBS)

Treatment-Resistant Patients

The group of patients from NCT03944213

Device: intermittent theta burst stimulation (iTBS)

Interventions

intermittent theta burst stimulation (iTBS) DEVICE

20 sessions of iTBS

Non-Treatment Resistant Patients; Treatment-Resistant Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients at the psychiatric hospital of the University Hospital Bonn. The patients diagnosis of major depressive disorder will be verified via the structured clinical interview for DSM-5. iTBS protocols in line with international standards administered by a trained professional.

You may qualify if:

• Participant is able to provide consent.
• Diagnosis of Major Depressive Disorder according to DSM-V criteria.
• The duration of the current episode is at least four weeks and no more than five years.
• During the current episode, pharmacological intervention was prescribed (and taken) by the patient

You may not qualify if:

• The participant does not fulfill requirements for iTBS treatment according to safety guidelines.
• Cardiac or neurological surgery, active implants, metal parts within the body, claustrophobia.
• Pregnancy or breast-feeding.
• Psychiatric illness, e.g. substance abuse, psychosis, bipolar disorder, anorexia, obsessive compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder, personality disorder.
• Antipsychotic medication not approved for the treatment of depression.
• Acute suicidality.
• Conditions related to increased intracranial pressure.
• Brain injury or stroke.
• History of epilepsy in patient or in first-degree relative.
• Cerebral aneurysm.
• Neurological illness (e.g. dementia (score of less than 25 in Mini Mental State Exam), Parkinson's disease, chorea huntington, multiple sclerosis).
• Course of electroconvulsive therapy (ECT) within the last three months

Sponsors & Collaborators

• University Hospital, Bonn: lead
• Maximilian Kiebs, M.S.: collaborator
• Clemens Mielacher, M.S.: collaborator

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, North Rhine-Westphalia, 53105, Germany

RECRUITING

Related Publications (6)

• Fregni F, Marcolin MA, Myczkowski M, Amiaz R, Hasey G, Rumi DO, Rosa M, Rigonatti SP, Camprodon J, Walpoth M, Heaslip J, Grunhaus L, Hausmann A, Pascual-Leone A. Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. Int J Neuropsychopharmacol. 2006 Dec;9(6):641-54. doi: 10.1017/S1461145705006280. Epub 2005 Nov 23.

  PMID: 16939662 BACKGROUND

• Brakemeier EL, Luborzewski A, Danker-Hopfe H, Kathmann N, Bajbouj M. Positive predictors for antidepressive response to prefrontal repetitive transcranial magnetic stimulation (rTMS). J Psychiatr Res. 2007 Aug;41(5):395-403. doi: 10.1016/j.jpsychires.2006.01.013. Epub 2006 Mar 22.

  PMID: 16554071 BACKGROUND

• Lisanby SH, Husain MM, Rosenquist PB, Maixner D, Gutierrez R, Krystal A, Gilmer W, Marangell LB, Aaronson S, Daskalakis ZJ, Canterbury R, Richelson E, Sackeim HA, George MS. Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009 Jan;34(2):522-34. doi: 10.1038/npp.2008.118. Epub 2008 Aug 13.

  PMID: 18704101 BACKGROUND

• Mutz J, Vipulananthan V, Carter B, Hurlemann R, Fu CHY, Young AH. Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ. 2019 Mar 27;364:l1079. doi: 10.1136/bmj.l1079.

  PMID: 30917990 BACKGROUND

• Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.

  PMID: 22658708 BACKGROUND

• Kiebs M, Hurlemann R, Mutz J. Repetitive transcranial magnetic stimulation in non-treatment-resistant depression. Br J Psychiatry. 2019 Aug;215(2):445-446. doi: 10.1192/bjp.2019.75. Epub 2019 Apr 24.

  PMID: 31014413 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Rene Hurlemann, Prof.

CONTACT

0049228287; rene.hurlemann@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Medical Psychology Division, Vice Head Psychiatry Department, Principal Investigator, Full Professor

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: January 1, 2019
• Primary Completion: December 29, 2023
• Study Completion: May 1, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

DE (1)