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New treatment option for Bipolar Depression
Official title Theta-Burst Stimulation for Bipolar Depression
ClinicalTrials.gov ID: NCT06370988
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- The participant must meet all of the 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...
- Age 18-65;
You likely can't join if
- 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;
See the full eligibility criteria
- The participant must meet all of the 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);
- Age 18-65;
- 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...
- 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...
- able to adhere to the treatment schedule;
- pass the TMS adult safety screening questionnaire.45
- 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;
- 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...
- 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;
- 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...
- are currently taking lorazepam \>2 mg daily (or equivalent) due to the potential to limit rTMS how well it works;
- are currently taking any dose of an anticonvulsant due to the potential to limit rTMS how well it works. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening...
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.