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New treatment option for Bipolar Depression Depressed Phase
Official title Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
ClinicalTrials.gov ID: NCT06986460
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- older than 18 years;
- failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17.
You likely can't join if
- 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;
- have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;
- have psychotic symptoms within the current episode;
See the full eligibility criteria
Who can join
- 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...
- older than 18 years;
- failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17.
- Score ≥10 on PHQ-9 at both (i) the 6 weeks follow-up in the TRIBE trial and (ii) at screening;
- ≤3 months from completion of the TRIBE study;
- 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...
- currently receiving treatment with one of the following non-anticonvulsant mood stabilizer with evidence for prevention of mania: lithium, quetiapine, asenapine, aripiprazole, paliperidone (\>6mg), risperidone...
- able to adhere to the treatment schedule;
- pass the TMS adult safety screening questionnaire.
What rules you out
- 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;
- 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 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;
- if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic...
- have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
- 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 to allow sufficient drug clearance;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
- participant was withdrawn from the TRIBE study due to safety concerns or at the discretion of the PI.
- any history of substance use in the last 4 weeks which poses a safety concern to undergo rTMS as assessed by the PI's review of responses to the trial's 'Substance Use Screening Questions Form'.
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 and older. 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.