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Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety

Major Depressive Disorder | Major Depressive Episode

This trial compares intermittent theta-burst stimulation (iTBS) to low frequency repetitive transcranial magnetic stimulation (LFR) in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression (TRD).

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

1. are outpatients;
2. are voluntary and competent to consent to treatment;
3. are ≥ 18 years;
4. have a score ≥ 26 on the IDS-30-SR;
5. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
6. able to adhere to the treatment schedule;
7. pass the TMS adult safety screening (TASS) questionnaire

Exclusion Criteria:

1. have active suicidal intent;
2. are pregnant;
3. have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
4. have a concomitant major unstable medical illness;
5. have any significant form of dementia or any history of epilepsy;
6. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
7. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
8. If they are taking psychotropic medication, be on a stable dose for 4 weeks before starting treatment, and no initiation of new regular psychotropic medication;
9. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Lieu de l'étude

Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Backup Contact

Fidel Vila-Rodriguez, M.D., Ph.D.

Primary Contact

Afifa Humaira, B.Sc.

[email protected]
604-822-7308
Étude parrainée par
University of British Columbia
Participants recherchés
Plus d'informations
ID de l'étude: NCT05028738