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出境医 / 临床实验 / Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve Patients With Major Depression (NAIV)

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Rene Hurlemann, Prof. 0049228287 ext 19124 rene.hurlemann@ukbonn.de

Locations
Layout table for location information
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.
Tracking Information
First Submitted Date June 25, 2019
First Posted Date June 27, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date December 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve Patients With Major Depression
Official Title Comparative Efficacy of Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve and Treatment Resistant Patients With Major Depression
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Major Depressive Disorder
Intervention Device: intermittent theta burst stimulation (iTBS)
20 sessions of iTBS
Study Groups/Cohorts
  • Non-Treatment Resistant Patients
    Intervention: Device: intermittent theta burst stimulation (iTBS)
  • Treatment-Resistant Patients
    The group of patients from NCT03944213
    Intervention: Device: intermittent theta burst stimulation (iTBS)
Publications *
  • 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. Epub 2005 Nov 23. Review.
  • 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. Epub 2006 Mar 22.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 25, 2019) 		20
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date December 29, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000022
Other Study ID Numbers NAIV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rene Hurlemann, University Hospital, Bonn
Study Sponsor University Hospital, Bonn
Collaborators
  • Maximilian Kiebs, M.S.
  • Clemens Mielacher, M.S.
Investigators Not Provided
PRS Account University Hospital, Bonn
Verification Date June 2019

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