Understanding relapse in major depressive disorder
Predictors of Early Relapse During Follow-up of Remitted Major Depression
This study is trying to find out what factors can help predict when people with major depressive disorder might relapse so that doctors can better prevent it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06746155 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictors of relapse in individuals with major depressive disorder (MDD) by monitoring various factors such as clinical symptoms, physical activity, sleep patterns, cognitive functioning, and brain activity over an 18-month period. Participants will wear a motion tracker and complete self-reported assessments weekly, while also undergoing bi-monthly follow-ups to evaluate their depressive symptoms. The goal is to develop a predictive model that can help healthcare providers anticipate and prevent relapse in patients who have achieved remission.
Who should consider this trial
Good fit: Ideal candidates for this study are outpatients aged 18 to 70 who meet the DSM-V criteria for MDD and are currently responding to treatment or have achieved remission.
Not a fit: Patients with bipolar disorder, schizophrenia, or those at elevated risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a valuable tool for healthcare providers to better monitor and prevent relapses in patients with major depressive disorder.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding relapse patterns in mental health conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatients 18 to 70 years of age. * Meet DSM-V criteria for MDD as determined by the SCID-5. * In the current or most recent MDE, participant must be responding or responded to a treatment or a combination of treatments for MDD. Patients with remitted MDD who are currently not taking medications will also be accepted. * Participants must have a MADRS total score ≤14. * Participant must be willing and able to complete self-reported assessments including sufficient fluency in English. * Participant must be willing to wear the wrist-worn actigraphic device for the duration of the study. Exclusion Criteria: * Bipolar I or Bipolar-II diagnosis (lifetime), schizophrenia, or schizoaffective disorder. * Elevated risk of suicide, as determined by clinical evaluation. * Existence of major neurological disorders, head injury (if accompanied by any of \[A\] loss of consciousness longer than 24 hours, \[B\] documented evidence of Glasgow Coma Scale \<9 at the time of injury, \[C\] post-traumatic amnesia lasting longer than 24 hours) (43), or other unstable medical conditions. * The participant presents with any condition which, according to the researcher's judgment, could interfere with the assessments stipulated in the protocol. * The participant is employed by the researcher, actively involved in the current study or other research overseen by the same researcher, or is a relative of a study employee or the researcher.
Where this trial is running
Halifax, Nova Scotia
- Nova Scotia Health — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Vanessa Pardo, BA (Hons)
- Email: CPSY@nshealth.ca
- Phone: 902-473-2697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.