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

NCT ID: NCT04000022

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-05-01

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.

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) has become a safe and efficacious treatment for patients with treatment-resistant depression (Mutz et al., 2019). Consequently, several countries including Australia, Brazil, Canada, Israel and the United States have approved rTMS as second-line treatment for major depressive disorder (MDD), while others have included rTMS in their guidelines for good clinical practice (e.g. Finland, Germany and Serbia). Historically, rTMS was conceptualized as a "soft" alternative to electroconvulsive therapy. Therefore, most studies to date primarily recruited patients with relatively high degrees of treatment-resistance (> two failed treatment attempts) and there is a lack of trials investigating rTMS as a first or second line treatment. This finding is contrasted by the fact that on the most stable predictors of response to rTMS is low-treatment resistance.

Therefore, this trial aims to compare the antidepressant efficacy of 20 pharmaco-naïve patients with 20 treatment-resistant patients diagnosed with major depressive disorder. In this open label trial, patients will receive four weeks high-frequency left-sided theta burst TMS (lDLFPC). The target will be located by neuronavigation to the target ascertained by Fox et al.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Treatment Resistant Patients

intermittent theta burst stimulation (iTBS)

Intervention Type: DEVICE

20 sessions of iTBS

Treatment-Resistant Patients

The group of patients from NCT03944213

intermittent theta burst stimulation (iTBS)

Intervention Type: DEVICE

20 sessions of iTBS

Interventions

intermittent theta burst stimulation (iTBS)

20 sessions of iTBS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maximilian Kiebs, M.S.

UNKNOWN

Sponsor Role: collaborator

Clemens Mielacher, M.S.

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Rene Hurlemann

Head Medical Psychology Division, Vice Head Psychiatry Department, Principal Investigator, Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Rene Hurlemann, Prof.

Role: CONTACT

rene.hurlemann@ukbonn.de

0049228287 ext. 19124

Facility Contacts

Maximilian Kiebs, M.Sc.

Role: primary

m.kiebs@ukbonn.de

0228287 ext. 19710

References

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.

Reference Type: BACKGROUND

PMID: 16939662 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16554071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18704101 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30917990 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22658708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31014413 (View on PubMed)

Other Identifiers

NAIV

Identifier Type: -

Identifier Source: org_study_id