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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • MagPro X100/R30 stimulator, Cool-B70 coil

    Device

    1Hz rTMS delivered to the right DLPFC

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Low frequency (1Hz) rTMS to the Right Dorsolateral Prefrontal CortexExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

Our primary analysis will be observational, and will calculate the change of the HRSD-17 score from baseline to completion of treatment (i.e., 6 weeks) as the primary outcome. Our primary analysis will be a student's paired t-test to compare the change from baseline to after 6 weeks of treatment with alpha set to 0.05. We will also report the standardized difference to determine the magnitude of change from baseline to completion of treatment.

Time frame
6 weeks

Secondary outcomes

1

Symptoms of hypomania/mania

Our secondary analysis will also be observational, and will calculate the change of the YMRS score from baseline to completion of treatment (i.e., 6 weeks) as a secondary outcome. Our primary analysis will be a student's paired t-test to compare the change from baseline to after 6 weeks of treatment with alpha set to 0.05. We will also report the standardized difference to determine the magnitude of change from baseline to completion of treatment.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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