Printed from Voxsanity (voxsanity.com.au) — NCT06370988 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Bipolar Disorder
Bipolar Disorder Trial, Recruiting
NCT06370988
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are able to understand and agree to participate in the study on your own
- You are currently being treated as an outpatient (not staying in hospital)
- You have been diagnosed with bipolar disorder (type I or II) and are currently in a depressive episode, confirmed by a structured interview
- You are between 18 and 65 years old
- You have tried at least one adequate medication treatment for bipolar depression without it working well enough, OR you were unable to tolerate at least two medication treatments
- You are currently experiencing moderately severe depression, based on a standard questionnaire score of 15 or higher (PHQ-9)
- You are not currently going through a mixed or manic episode
- You have not started or increased any psychiatric medications for depression in the 4 weeks before screening (some sleep medications are exceptions — confirm with trial site)
- You are able to attend and follow the treatment schedule
- You pass a standard safety questionnaire for brain stimulation treatment (TMS)
Who may not be able to join:
- You have had a diagnosed substance use disorder (other than nicotine or caffeine) within the last 3 months
- You have a serious unstable physical health condition
- You are currently having active thoughts of suicide with a specific plan and intention to act on it
- You are pregnant or planning to become pregnant during the study
- You have ever been diagnosed with schizophrenia or schizoaffective disorder
- You are experiencing psychotic symptoms during your current episode
- You have an anxiety disorder, trauma-related disorder, OCD, or personality disorder that is considered more significant than your bipolar depression (confirm with trial site)
- You have already tried a full course of electroconvulsive therapy (ECT) during the current episode without it helping
- You have previously received repetitive TMS (rTMS) treatment at any point in your life
- You have a significant neurological condition (such as a recent stroke) or a history of seizures (with some exceptions — confirm with trial site)
- You have metal implants or other metal objects in or near your head that cannot be safely removed
- You have started a new psychotherapy within the last 3 months (those in stable therapy for 3 or more months may still be eligible — confirm with trial site)
- You are currently taking more than 2mg of lorazepam daily (or an equivalent dose of a similar medication)
- You are currently taking any anti-seizure (anticonvulsant) medication (confirm with trial site regarding timing if recently stopped)
- You have a significant hearing or sensory impairment that cannot be corrected and would make it hard to participate in interviews
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Phone: 416-535-8501
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Centre for Addiction and Mental Health
Registry
ClinicalTrials.gov
Start date
15 May 2024
Est. completion
1 May 2029
Where this trial is recruiting
🇨🇦 Canada
Primary endpoints
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.