| NCT ID | NCT06972368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ciusss de L'Est de l'Île de Montréal |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present study aims to assess the feasibility of home-based tDCS in remote and urban areas (primary objective). The secondary aim is to obtain a preliminary assessment of the efficacy of 14 home-based tDCS sessions in reducing depressive symptoms in BPD patients with moderate to severe depressive episodes and BPD symptoms. Exploratory objectives include assessing the impact on neuropsychological and psychosocial functioning, anxiety, physical activity, sleep disorders, and addiction. Additionally, we aim to investigate the sociodemographic and clinical factors that are linked to the most favorable response to tDCS in addressing both depressive and BPD symptoms. We also aim to assess the feasibility of using a smartwatch as an outcome measure in this population. Finally, we intend to gather preliminary data on the effectiveness of an online psychoeducational program specifically designed for patients with BPD. Researchers will compare active tDCS to sham tDCS to see if active treatment is more effective in treating depression in this population. Participants will: * Receive 14 sessions of either active or sham tDCS over one week, delivered at home * Complete psychological and neurocognitive assessments at baseline, post-treatment, and at 6 weeks * Wear actigraphy monitors and complete questionnaires to assess sleep, physical activity, and other mental health outcomes This trial will also explore the feasibility of delivering tDCS in both urban and rural settings.
Eligibility Criteria
Inclusion Criteria: 1. To be aged between 18 and 65. 2. To meet the DSM-IV criteria for BPD. 3. To present a moderate depressive episode, defined as a MADRS score ≥ 20 (V1 and V3). 4. To be capable to consent to participate in the study. 5. To speak either French or English. 6. Participants must have a prescribing doctor or mental health professional responsible 7. To maintain a stable psychopharmacological and psychotherapeutic intervention. 8. To have access to internet an a smartphone. 9. To demonstrate proficiency in independently using a tDCS device. 10. To be able to pick up and return the remote tDCS device. Exclusion Criteria: \- 1. To have a history of Epilepsy. 2. To have a contraindication for tDCS Medical Devices. 3. To have a history of Cerebrovascular Surgery. 4. To present scalp Conditions Affecting tDCS Electrode Placement. 5. To have a history of bipolar disorder. 6. To present social or medical conditions limiting the autonomous use of remote tDCS. 7\. To be pregnant. 8. To be currently undergoing neuromodulation treatment. 9. To be currently using benzodiazepines.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06972368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06972368 currently recruiting?
Yes, NCT06972368 is actively recruiting participants. Contact the research team at lionel.cailhol.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06972368 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06972368 clinical trial?
NCT06972368 is sponsored by Ciusss de L'Est de l'Île de Montréal. The trial plans to enroll 60 participants.