High Dose Accelerated ITBS for Depression

Last updated: January 27, 2025
Sponsor: Centre for Addiction and Mental Health
Overall Status: Completed

Phase

N/A

Condition

Depression

Depression (Major/severe)

Affective Disorders

Treatment

Sham iTBS

Active iTBS

Clinical Study ID

NCT04255784
109-2019
  • Ages 18-65
  • All Genders

Study Summary

This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. are outpatients

  2. are voluntary and competent to consent to treatment

  3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis ofMDD, single or recurrent

  4. are between the ages of 18 and 65

  5. have failed to achieve a clinical response to an adequate dose of an antidepressantbased on an Antidepressant Treatment History Form (ATHF) score for thatantidepressant trial of > 3 in the current episode OR have been unable to tolerateat least 2 separate trials of antidepressants of inadequate dose and duration (ATHFscore of 1 or 2 on those 2 separate antidepressants)

  6. have a score > 18 on the HRSD-17 item

  7. have had no increase or initiation of any psychotropic medication in the 4 weeksprior to screening

  8. able to adhere to the treatment schedule

  9. Pass the TMS adult safety screening (TASS) questionnaire

  10. have normal thyroid functioning based on pre-study blood work.

Exclusion

Exclusion Criteria:

  1. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis ofsubstance dependence or abuse within the last 3 months

  2. have a concomitant major unstable medical illness, cardiac pacemaker or implantedmedication pump

  3. have active suicidal intent

  4. are pregnant

  5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis ofbipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniformdisorder, delusional disorder, or current psychotic symptoms

  6. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stressdisorder (current or within the last year), anxiety disorder (generalized anxietydisorder, social anxiety disorder, panic disorder), or dysthymia, that is assessedby a study investigator to be primary and causing greater impairment than MDD

  7. have a diagnosis of any personality disorder, and assessed by a study investigatorto be primary and causing greater impairment than MDD

  8. have failed a course of ECT in the current episode or previous episode

  9. have received rTMS for any previous indication due to the potential compromise ofsubject blinding

  10. have any significant neurological disorder or insult including, but not limited to:any condition likely to be associated with increased intracranial pressure, spaceoccupying brain lesion, any history of seizure except those therapeutically inducedby ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease,Huntington's chorea, multiple sclerosis, significant head trauma with loss ofconsciousness for greater than 5 minutes

  11. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlearimplants, or electrodes) or any other metal object within or near the head,excluding the mouth, that cannot be safely removed

  12. if participating in psychotherapy, must have been in stable treatment for at least 3months prior to entry into the study, with no anticipation of change in thefrequency of therapeutic sessions, or the therapeutic focus over the duration of thestudy

  13. clinically significant laboratory abnormality, in the opinion of the one of theprincipal investigators or study physicians

  14. currently take more than lorazepam 2 mg daily (or equivalent) or any dose of ananticonvulsant due to the potential to limit rTMS efficacy

  15. non-correctable clinically significant sensory impairment (i.e., cannot hear wellenough to cooperate with interview).

Study Design

Total Participants: 228
Treatment Group(s): 2
Primary Treatment: Sham iTBS
Phase:
Study Start date:
February 06, 2020
Estimated Completion Date:
January 24, 2025

Study Description

Those participants who do not meet the response criterion (50% improvement from baseline on the HRDS-17) at the 4-week follow-up will be offered a second course of treatment, regardless of whether they were in the active or the sham treatment group. The blind will be maintained and no further assessment contributing to the primary or secondary outcomes will occur after the 4-week time point. A different operator will administer the open-label second course of treatment to ensure blinding of operators. The second course of treatment will apply active rTMS using low-frequency (1 Hz) stimulation to the right DLPFC for 600 pulses (10 minutes), 8x daily at 50 minutes (between session and end and start) intervals for 5 days. All those completing the second course of treatment will undergo the same set of clinical assessments during and after the course of treatment on the same schedule as the first course of treatment. The final 4-week follow up assessment from the first course of treatment will serve as the baseline for those that go on to receive the second open label treatment course.

Connect with a study center

  • University of British Columbia

    Vancouver, British Columbia V6T2A1
    Canada

    Site Not Available

  • CAMH

    Toronto, Ontario M6J1H4
    Canada

    Site Not Available

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