Depressive Disorder, Treatment-Resistant
Conditions
Interventions
This is an open-label, non-controlled pilot clinical trial with a single intervention group. A total of 30 adult participants aged between 18 and 65 years, diagnosed with treatment-resistant depressio
Sponsors
Faculdade de Ciências Médicas da Universidade de Pernambuco
Faculdade de Ciências Médicas da Universidade de Pernambuco
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults of both sexes; age between 18 and 65 years; diagnosis of major depressive disorder; failure to respond to at least two adequate antidepressant treatments; baseline Montgomery-Åsberg Depression Rating Scale score greater than or equal to twenty, indicating moderate depression
Exclusion criteria
Exclusion criteria: Diagnosis of bipolar disorder; presence of psychotic symptoms in the current depressive episode; pregnant or breastfeeding individuals; use of neuromodulation treatments within the past twelve months, including transcranial direct current stimulation, transcranial magnetic stimulation, or electroconvulsive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe treatment response in patients with treatment-resistant depression, characterized by a clinically meaningful reduction in depressive symptoms, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), based on the identification of a reduction of at least 50% in MADRS scores from baseline to the end of four weeks of transcranial photobiomodulation treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to identify clinical remission rates after treatment, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), based on the observation of scores below 10 points at the end of four weeks of transcranial photobiomodulation intervention.;It is expected to evaluate the maintenance of treatment response and clinical remission during follow-up, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), based on the observation of sustained =50% reduction in MADRS scores and/or scores below 10 points at weeks 4, 8, and 12 after treatment completion.;It is expected to observe a reduction in self-reported depressive symptoms, assessed using the Quick Inventory of Depressive Symptomatology – Self-Report 16 items (QIDS-SR16), based on the identification of decreased scores from baseline to the end of the four-week intervention period.;It is expected to identify global clinical improvement in participants after treatment, assessed using the Clinical Global Impression (CGI), based on the observation of reduced severity scores and improved global clinical impression scores from baseline to the end of the intervention.;It is expected to evaluate the tolerability and safety of transcranial photobiomodulation treatment, assessed through systematic recording of adverse events, based on the observation of the frequency, intensity, and severity of reported events during the intervention and follow-up periods. | — |
Countries
Brazil
Contacts
Public ContactDennison Monteiro
Instituto Monteiro de Neuromodulação
Outcome results
None listed