Clinical trial for Depression
Official title Left vs. Right Non-Inferiority Trial
ClinicalTrials.gov ID: NCT04999553
What this study is testing
- What it's testing
- The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for 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 to 65
You may be able to join if
- are female or male;
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0;
- are 18yo to 65yo;
You likely can't join if
- have a history of substance use within the last 3 months;
- have a concomitant major unstable medical illness;
- have active suicidal intent;
- are pregnant;
- have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;
- have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD;
See the full eligibility criteria
- are female or male;
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0;
- are 18yo to 65yo;
- have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of \> 3 in the current episode OR have been unable to tolerate at least...
- have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item);
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
- are able to adhere to the treatment schedule;
- pass the TMS and MRI adult safety screening questionnaires.
- have a history of substance use within the last 3 months;
- have a concomitant major unstable medical illness;
- have active suicidal intent;
- are pregnant;
- have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;
- have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD;
- have failed a course of ECT in the current episode;
- have any significant neurological disorder, any history of seizure (except those therapeutically induced by ECT), significant head trauma with loss of consciousness for \> 5 min;
- have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- are participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions...
- 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
- Toronto, Ontario, 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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Toronto, Ontario, 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.