Depression and Anxiety Trial, Recruiting NCT07413705 Sponsor: BTL Industries Ltd. Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT07413705
Recruiting Not Applicable

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:

  • People who are in menopause (no periods for 12 months in a row, with no other medical explanation) or perimenopause (no periods for at least 60 days, with no other medical explanation)
  • People who score 5 or higher on a standard depression questionnaire called the PHQ-9, measured before treatment begins
  • People aged 40 or older
  • People for whom a specific brain stimulation measurement (called a motor threshold) can be successfully established by the trial team
  • People who are willing to avoid other treatments for depression or sexual function — including other brain stimulation therapies — for the entire time they are in the study
  • People who are willing to follow study instructions and attend all required clinic visits
  • People who are not permanently sterile or postmenopausal and who are willing to use contraception for the full duration of the study
  • People who, if already on a stable mental health medication or therapy, have been on that same treatment at the same dose for at least one month before joining the study

Who may not be able to join:

  • People with metal objects in or near the head, or within 30 cm of where the treatment would be applied (note: standard dental fillings, single dental implants, bridgework, and braces may still be acceptable — confirm with trial site)
  • People with any implanted devices such as deep brain stimulators, cochlear implants, eye implants, or vagus nerve stimulators
  • People with a cardiac pacemaker or implanted defibrillator
  • People with any other electronic or metal implants in the body
  • People with an implanted drug pump
  • People who have or are prone to seizures, including those with epilepsy or low muscle tone (hypotonia)
  • People currently on blood-thinning (anticoagulation) medication
  • People with a severe or life-threatening illness
  • People with serious lung, heart, or kidney problems
  • People with certain uncontrolled bleeding or blood-clotting disorders, or uncontrolled cardiovascular (heart and blood vessel) disease (confirm with trial site for exact definitions)
  • People with any type of tumour, whether cancerous or non-cancerous
  • People who currently have a fever
  • People who are pregnant or breastfeeding
  • People with active thoughts of suicide or a history of suicide attempts in the last 3 years
  • People who have previously had, or are currently receiving, electroconvulsive therapy (ECT) or vagus nerve stimulation
  • People whose depression is caused by substance use or by another medical condition
  • People diagnosed with seasonal affective disorder, a psychotic disorder (including schizoaffective disorder), major depression with psychotic features, or bipolar disorder
  • People with a current substance abuse problem, or who had a substance dependence issue in the 3 months before joining
  • People with neurological conditions, including a history of seizures, stroke, brain tumours, brain aneurysm, dementia, or movement disorders
  • People with a history of increased pressure in the skull or a significant head injury
  • People with an active eating disorder such as bulimia or anorexia, or who have experienced one in the past 12 months
  • People with any other condition or situation that, in the investigator's judgement, could put them at risk or affect the study results

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.
Last synced 27 July 2026
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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
BTL Industries Ltd.
Registry
ClinicalTrials.gov
Start date
20 November 2025
Est. completion
11 December 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 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.

View original record on ClinicalTrials.gov