Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression (NCT06986460) | Clinical Trial Compass
RecruitingPhase 3
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Canada80 participantsStarted 2025-05-27
Plain-language summary
The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering. Participants will come for 30 days of LFR, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must be deemed to have capacity to provide informed consent;
✓. Must be an outpatient;
✓. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI) assessed during TRIBE trial participation with no contradictory evidence that the current episode is depressed from FLARE trial screening assessments (YMRS\>10/PHQ-9 \<10);
✓. older than 18 years;
✓. failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17.
✓. Score ≥10 on PHQ-9 at both (i) the 6 weeks follow-up in the TRIBE trial and (ii) at screening;
✓. ≤3 months from completion of the TRIBE study;
✓. not currently experiencing a mixed or manic episode (YMRS ≤10);
Exclusion criteria
✕. have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;
What they're measuring
1
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
✕. have a concomitant major unstable medical illness;
✕. have active suicidal intent;
✕. are pregnant or intend to get pregnant during the study;
✕. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;
✕. have psychotic symptoms within the current episode;
✕. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE;
✕. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;