Theta-Burst Stimulation for Bipolar Depression

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called intermittent theta-burst stimulation (iTBS) to see if it can help reduce symptoms of depression in people with bipolar disorder who have not found relief from other treatments. Participants will be divided into two groups: one will receive the active iTBS treatment, while the other will receive a placebo (sham) treatment that doesn’t have any therapeutic effect. The study lasts for 30 days, followed by a 6-week follow-up period to assess how well the treatment worked and to check for any side effects.

To be eligible for this trial, participants should be between 18 and 65 years old, diagnosed with bipolar disorder (either type I or II), and currently experiencing moderate to severe depression. They must also have tried at least one other treatment for their depression without success. Participants will attend sessions where they receive the treatment five times a week, and their symptoms will be monitored throughout the study. It's important to know that individuals with certain conditions, such as those with active suicidal thoughts or significant medical illnesses, won't be able to participate. This trial aims to provide new options for those struggling with treatment-resistant bipolar depression.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• The participant must meet all of the inclusion criteria to eligible for this clinical trial:
• • 1. Must be deemed to have capacity to provide informed consent;
• • 2. Must be an outpatient
• • 3. 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);
• • 4. Age 18-65;
• • 5. 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
• • 6. moderately severe depression with a score ≥ 15 on the PHQ-9;44
• • 7. not currently experiencing a mixed or manic episode (YMRS ≤10);
• • 8. 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;
• • 9. able to adhere to the treatment schedule;
• • 10. 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:
• • 1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;
• • 2. have a concomitant major unstable medical illness;
• • 3. have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);
• • 4. are pregnant or intend to get pregnant during the study;
• • 5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;
• • 6. have psychotic symptoms within the current episode;
• • 7. 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;
• • 8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;
• • 9. have received any rTMS before due to potential to compromise blinding of treatment allocation;
• • 10. have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);
• • 11. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
• • 12. are participating in psychotherapy for less than 3 months. Patients will be permitted if they 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 over the duration of the study;
• • 13. are currently taking lorazepam \>2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;
• • 14. are currently taking any dose of an anticonvulsant due to the potential to limit rTMS efficacy. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;
• • 15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).