Exercise program for patients with treatment-resistant depression
Exercise Program in Patients With Treatment-resistant Depressive Disorder Compared to Usual Practice
This study is testing if a special exercise program can help people with treatment-resistant depression feel better when other medications haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Sponsor | University of the Basque Country (UPV/EHU) Academic / other |
| Locations | 1 site (Vitoria Gasteiz) |
| Trial ID | NCT05136027 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a combined exercise program on patients suffering from treatment-resistant major depressive disorder (TRD). It aims to assess whether low-intensity interval training and resistance training can improve symptoms and functionality in individuals who have not responded adequately to at least two different antidepressant treatments. The approach recognizes the high prevalence of depression and the limitations of current pharmacological options, exploring exercise as a viable complementary intervention. Participants will be closely monitored to ensure safety and adherence to the exercise regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with major depressive disorder who have not responded to at least two different antidepressant treatments.
Not a fit: Patients with schizophrenia, active substance use disorders, or those at risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide a non-pharmacological treatment option that significantly improves the quality of life for patients with treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results for exercise as an adjunct treatment for depression, suggesting that this approach may be beneficial for treatment-resistant cases as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Depression major disorder. * 2 or more antdepressives resistant a treatment. * Consent informed signed Exclusion Criteria: * Schizophrenia or other disorders. * Suicide risk. * Unstable medic illness or unsuitable controlled. * Disorder for use of active substances. * Comorbidity with other psychiatric pathologies. * Montreal Cognitive Assessment \<26/30, cognitive deterioration. * Incapacity for realizing physical exercise because of osteoarticular, cardiovascular, or metabolic difficulty.
Where this trial is running
Vitoria Gasteiz
- Basque Country University — Vitoria Gasteiz, Spain (Recruiting)
Study contacts
- Principal investigator: Nagore Iriarte-Yoller, Md — Psychiatric Hospital of Álava
- Study coordinator: Sara Maldonado-Martin, PhD
- Email: sara.maldonado@ehu.eus
- Phone: 34945013534
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.