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

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ClinicalTrials.gov Identifier: NCT04000022
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborators:
Maximilian Kiebs, M.S.
Clemens Mielacher, M.S.
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

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.

Condition or disease Intervention/treatment
Major Depressive Disorder Device: intermittent theta burst stimulation (iTBS)

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Efficacy of Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve and Treatment Resistant Patients With Major Depression
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non-Treatment Resistant Patients Device: intermittent theta burst stimulation (iTBS)
20 sessions of iTBS

Treatment-Resistant Patients
The group of patients from NCT03944213
Device: intermittent theta burst stimulation (iTBS)
20 sessions of iTBS




Primary Outcome Measures :
  1. Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS-17) over 7 timepoints [ Time Frame: Six weekly measurements starting 1 week before first iTBS treatment session, one follow-up measurement four weeks after last measurement ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000022


Contacts
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Contact: Rene Hurlemann, Prof. 0049228287 ext 19124 rene.hurlemann@ukbonn.de

Locations
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Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
Contact: Maximilian Kiebs, M.Sc.    0228287 ext 19710    m.kiebs@ukbonn.de   
Sponsors and Collaborators
University Hospital, Bonn
Maximilian Kiebs, M.S.
Clemens Mielacher, M.S.

Publications:

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Responsible Party: Rene Hurlemann, Head Medical Psychology Division, Vice Head Psychiatry Department, Principal Investigator, Full Professor, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT04000022     History of Changes
Other Study ID Numbers: NAIV
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rene Hurlemann, University Hospital, Bonn:
Major Depressive Disorder
rTMS
TBS
Theta Burst Stimulation
Neuronavigation
Non-Treatment Resistant
Pharmaco-Naïve
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders