Depression and Anxiety Trial, Recruiting NCT06773949 Sponsor: The Royal Ottawa Mental Health Centre Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT06773949
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 aged between 18 and 75 years old.
  • People who are able to give their voluntary agreement to participate after being fully informed about the trial.
  • People who have been diagnosed with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (a long-lasting form of depression), without psychotic features, confirmed by a specific structured interview tool.
  • People whose depressive symptoms have not improved after at least one adequate antidepressant medication trial during their current episode of depression (sometimes called difficult-to-treat depression), as assessed using a standardised treatment history form.
  • People whose depression scores at least 15 points on a specific depression rating scale called the HRSD-17, indicating a moderate-to-severe level of symptoms.
  • People who have not changed their psychiatric medications or psychotherapy in the four weeks before joining the trial.
  • People who are considered physically inactive based on a standard physical activity questionnaire (IPAQ-SF).
  • People who are medically cleared to take part in structured exercise, as determined by a screening questionnaire called the Get Active Questionnaire.
  • People who are able to follow and attend the treatment schedule required by the trial.

Who may not be able to join:

  • People who have been diagnosed with Bipolar I or Bipolar II Disorder.
  • People who have had a problem with substance use or alcohol (excluding caffeine or nicotine) in the past three months or currently, as defined by standard diagnostic criteria.
  • People who are currently using illegal substances.
  • People who are currently using cannabis.
  • People who have a major unstable medical or neurological condition, such as uncontrolled diabetes or kidney problems.
  • People whose depression symptoms are caused by a physical or medical condition (for example, a thyroid problem), as determined by their referring doctor.
  • People who are considered at acute risk of suicide or whose life is at risk due to self-neglect.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
  • People who have a medical reason they cannot safely receive TMS (brain stimulation) or MRI, such as a personal history of epilepsy or seizures, a metallic implant in the head, or a pacemaker, as confirmed by specific safety screening tools.
  • People who are unwilling to keep their current psychiatric medications and/or psychotherapy unchanged for the four weeks before and throughout the duration of the study.
  • People who are taking more than 1 mg per day of lorazepam or an equivalent sedative medication.
  • People who, in the opinion of the research team, have any other condition that could interfere with their ability to complete the study.
  • People who are already physically active at a level that meets or exceeds the "minimally active" threshold on the physical activity questionnaire (IPAQ-SF).

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 6 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.

Contact this trial

Principal Investigator: Sara Tremblay, PhD, Royal Ottawa Mental Health Centre

Phone: 613-722-6521

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
The Royal Ottawa Mental Health Centre
Registry
ClinicalTrials.gov
Start date
15 December 2025
Est. completion
31 January 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Assessing feasibility on combining structured exercise and intermittent Theta Burst Stimulation (iTBS) in participants with treatment-resistant depression (TRD); Compare the effects on clinical response of exercise on enhancing iTBS treatment efficacy vs. iTBS alone

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: 6 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