Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
ConditionBipolar Depression Depressed Phase
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTyler Kaster
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;
have a concomitant major unstable medical illness;
have active suicidal intent;
are pregnant or intend to get pregnant during the study;
Trial design
Treatments tested in this trial
- MagPro X100/R30 stimulator, Cool-B70 coil
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Tyler Kaster
Lead sponsor
Centre for Addiction and Mental Health
Sponsor institution
The Poul Hansen Family Centre for Depression
Collaborator
Toronto Western Hospital, Canada
Collaborator
University Health Network, Toronto
Collaborator
Source ClinicalTrials.gov