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New treatment option for Major Depressive Episode
Official title Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety
ClinicalTrials.gov ID: NCT05028738
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- are outpatients;
- are voluntary and competent to consent to treatment;
- are ≥ 18 years;
- have a score ≥ 26 on the IDS-30-SR;
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
You likely can't join if
- have active suicidal intent;
- are pregnant;
- have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms...
- have a concomitant major unstable medical illness;
- have any significant form of dementia or any history of epilepsy;
- have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near...
See the full eligibility criteria
- are outpatients;
- are voluntary and competent to consent to treatment;
- are ≥ 18 years;
- have a score ≥ 26 on the IDS-30-SR;
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
- able to adhere to the treatment schedule;
- pass the TMS adult safety screening (TASS) questionnaire
- have active suicidal intent;
- are pregnant;
- have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
- have a concomitant major unstable medical illness;
- have any significant form of dementia or any history of epilepsy;
- 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;
- 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...
- 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;
- have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.