Theta-Burst Stimulation for Bipolar Depression
Overview
- Phase
- Not Applicable
- Intervention
- iTBS Stimulation
- Conditions
- Bipolar Depression
- Sponsor
- Centre for Addiction and Mental Health
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, 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.
Investigators
Tyler Kaster
Scientist
Centre for Addiction and Mental Health
Eligibility Criteria
Inclusion Criteria
- •The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- •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);
- •failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43
- •moderately severe depression with a score ≥ 15 on the PHQ-9;44
- •not currently experiencing a mixed or manic episode (YMRS ≤10);
- •no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \[3-6mg\], low-dose benzodiazepines \[≤2mg lorazepam daily equivalent\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;
- •able to adhere to the treatment schedule;
- •pass the TMS adult safety screening questionnaire.45
Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- •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 (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);
- •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;
- •have received any rTMS before due to potential to compromise blinding of treatment allocation;
Arms & Interventions
Active iTBS Stimulation
Administered once daily over 30 days. Each session will deliver 600 pulses of active iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of \~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold.
Intervention: iTBS Stimulation
Sham iTBS Stimulation
Administered once daily over 30 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 600 pulses of sham iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of \~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold.
Intervention: Sham iTBS Stimulation
Outcomes
Primary Outcomes
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Time Frame: From enrollment to 6 weeks post-treatment
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17), ITT, 6 weeks (completion of treatment phase (30 txs)). The main effect of interest is the interaction term between time since starting treatment and treatment allocation. This analytic approach incorporates longitudinal depressive symptom assessments throughout the trial rather solely at treatment completion.
Secondary Outcomes
- Symptoms of Mania(From enrollment to 6 weeks post-treatment)