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Magnetic Randomized Trial in Elderly Depressed (MrTED)

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ClinicalTrials.gov Identifier: NCT04842929
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Leandro Valiengo, University of Sao Paulo

Brief Summary:
Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness, adverse effects and drug interactions, especially in the elderly population. In this context, the investigators investigate a non-pharmacological treatment known as recurrent transcranial magnetic stimulation (rTMS) with the theta-burst stimulation (TBS) method for the treatment of geriatric depression. This treatment modality has almost no adverse effects and avoids the risk associated with polypharmacy, providing an interesting alternative to antidepressant treatments. Our aim is to evaluate TBS efficacy in the treatment of geriatric depression in a randomized, double-blind, placebo-controlled clinical trial.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial magnetic stimulation Not Applicable

Detailed Description:
Recurrent transcranial magnetic stimulation (rTMS) is a consolidated procedure for the treatment of depression, with several meta-analyzes demonstrating its efficacy. The theta-burst stimulation (TBS) method is a modification of the usual rTMS protocol. As a new protocol, there are still few studies evaluating its efficacy in treatment of major depression, although a recently published meta-analysis has pointed to benefits of this therapeutic modality. To date, there are no studies published with this method for the treatment of geriatric depression. This study will be a randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of theta-burst rTMS in the treatment of major depressive disorder in the elderly, randomizing 108 subjects to the experimental (TBS) and comparative (sham) groups. The coil will be positioned in the dorsolateral prefrontal cortex, with intermittent TBS (iTBS, stimulatory) mode on the left and continuous TBS (cTBS, inhibitory) on the right. Stimulation protocol consists of 1800 pulses on each brain hemisphere, totaling a ten minutes session. There will be 20 consecutive sessions, one a day, except on weekends and holidays. The cycle of continuous intervention will last approximately four weeks, after which applications with the same technique will be performed at the end of weeks 6, 8 and 12. Clinical outcome measures will be obtained on eight occasions: treatment baseline, and after 1, 2, 4, 6, 8 and 12 weeks of onset. The main clinical outcome will be measured using the Hamilton Depression Scale (HDRS), comparing baseline scores with those obtained after 6 weeks of treatment. As secondary endpoints, we will use the Global Clinical Impression Scale (CGI), the CIRS (Cumulative Illness Rating Scale), the Geriatric Depression Scale (GDS), the intermediate scores obtained on the HDRS scale, the Positive and Negative Affect Scale (PANAS), the Montgomery-Asberg Depression Rating Scale (MADRS), and variations in serum BDNF concentrations; all these evaluation tools have validated versions in Portuguese. As tolerability and safety parameters, the incidence of adverse events and the occurrence of manic/hypomanic symptoms will be evaluated by the Young Mania Scale (YMRS). TBS stimulation will be evaluated in terms of safety, tolerability and effectiveness for the treatment of major depression in the elderly, possibly becoming another therapeutic option useful for patients with poor response or contraindications to the use of antidepressants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression in the Elderly With Repetitive Transcranial Magnetic Stimulation (rTMS) Using Theta-burst Stimulation (TBS): Randomized, Double-blind, Sham-controlled, Clinical Trial
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : December 17, 2021
Estimated Study Completion Date : February 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Stimulation
Active Comparator: Active stimulation with pulses emitted according to intervention description
Device: Transcranial magnetic stimulation
The coil will be positioned in the prefrontal dorsolateral cortex, with intermintent TBS (TBSi) mode on the left and continuous TBS (TBSc) on the right. 1800 pulses will be used on each side, totaling 10 minutes of total duration. There will be 20 consecutive sessions, one per day, except on weekends and holidays, totaling around 4 weeks. A day of stimulation with the same technique will be done in the 6th week, 8th week and 12th week.

Sham Comparator: Sham Stimulation
Sham Comparator: The blinding will be done with a sham coil, which consists of a coil that reproduces the sound that the true coil does, but without generating the magnetic field.
Device: Transcranial magnetic stimulation
The coil will be positioned in the prefrontal dorsolateral cortex, with intermintent TBS (TBSi) mode on the left and continuous TBS (TBSc) on the right. 1800 pulses will be used on each side, totaling 10 minutes of total duration. There will be 20 consecutive sessions, one per day, except on weekends and holidays, totaling around 4 weeks. A day of stimulation with the same technique will be done in the 6th week, 8th week and 12th week.




Primary Outcome Measures :
  1. Changes in Hamilton Rating Scale for Depression, 17 items (HDRS-17) [ Time Frame: Weeks 0 and 6 ]
    Continuous measure (score changes).


Secondary Outcome Measures :
  1. Change in HDRS-17 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 ]
    Continuous measure (score changes).

  2. Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 ]
    Continuous measure (score changes).

  3. Change in Global Clinical Impression Scale (CGI) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 ]
  4. Change in Cumulative Illness Rating Scale (CIRS) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 ]
  5. Change in Geriatric Depression Scale (GDS) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 ]
  6. Change in Positive and Negative Affect Scale (PANAS) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 ]
  7. Change in serum BDNF concentrations [ Time Frame: Weeks 0 and 6 ]
  8. HDRS 17 [ Time Frame: Week 12 ]
    Response (≥50% improvement from week 0 to 12)

  9. HDRS 17 [ Time Frame: Week 12 ]
    Remission (HDRS-17 ≤ 8)

  10. Young Manic Rating Scale (YMRS) [ Time Frame: Weeks 0, 1, 2, 4, 6, 8, 12 ]
    Serious adverse events include treatment-emergent hypomania/mania (YMRS>8), suicide, psychiatric hospitalization and others life-threatening or incapacitant events

  11. Serious adverse events [ Time Frame: Up to week 12 ]
    Serious adverse events include treatment-emergent hypomania/mania (YMRS>8), suicide, psychiatric hospitalization and others life-threatening or incapacitant events


Other Outcome Measures:
  1. Conditioned pain modulation [ Time Frame: Week 0 and 4 ]
    Temperature of the thermode reported as painful

  2. Actigraphy [ Time Frame: 1 week before treatment up to 4 weeks after finishing study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major Depressive Disorder;
  • Patients older than 60 years
  • Hamilton equal or higher than 17

Exclusion Criteria:

  • Other mental disorders (alcohol or drug addiction, psychotic disorders, dementia, bipolar disorder);
  • Presence of serious neurological or clinical diseases;
  • Resence of severe suicidal ideation and CIRS (Cumulative Illness Rating Scale) score> 7, characterizing a set of clinical morbidities that could impair adherence to the research protocol, bipolar disorder and/or presence of manic symptoms (hypo) demonstrated with more than 8 points in the Young Mania Rating Scale.
  • Metal implants;
  • Epilepsy or electronics in the cephalic segment;

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): NCT04842929


Contacts
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Contact: Leandro Valiengo (11) 2661-8159 pesquisa.neuropsiquiatria@gmail.com

Locations
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Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil
Principal Investigator: Leandro Valiengo, MD         
Sponsors and Collaborators
University of Sao Paulo
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Leandro Valiengo University of São Paulo
  Study Documents (Full-Text)

Documents provided by Leandro Valiengo, University of Sao Paulo:
Study Protocol  [PDF] January 1, 2021
Informed Consent Form  [PDF] March 12, 2021

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Responsible Party: Leandro Valiengo, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04842929    
Other Study ID Numbers: 2.643.551
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leandro Valiengo, University of Sao Paulo:
major depressive disorder
geriatric depression
repetitive transcranial magnetic stimulation (rTMS)
theta-burst stimulation (TBS)
elderly
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms