Treatment Resistant Depression (TRD)
Conditions
Brief summary
Non-inferiority (with a 25% margin) in terms of percentage of clinical responders, defined as the reduction in Montgomery-Asberg Depression Rating Scale (MADRS) scores ≥ 50%, after 60 days from the start of the trial.
Detailed description
Hamilton Anxiety Rating Scale (HAM-A) score, Hamilton Depression Rating Scale (HAM-D) score, Brief Psychiatric Rating Scale (BPRS) score, Young Mania Rating Scale (YMRS) score, Snaith-Hamilton Pleasure Scale (SHAPS) scores for anhedonia, Columbia–Suicide Severity Rating Scale and Beck Hopelessness Scale scores for suicide risk, Trail Making Test for attention and executive functions, Clinical Global Impression Severity (CGIS) and Health Status Questionnaire scores for impact of symptoms on health, Functional magnetic resonance imaging (fMRI) analysis for changes in connectivity patterns in TRD-related brain networks, Electroencephalography (EEG) for changes in functional connectivity
Interventions
DRUGPCB2 (inert placebo containing maltodextrin)
Sponsors
Universita' Degli Studi G. D'Annunzio Di Chieti
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority (with a 25% margin) in terms of percentage of clinical responders, defined as the reduction in Montgomery-Asberg Depression Rating Scale (MADRS) scores ≥ 50%, after 60 days from the start of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) score, Hamilton Depression Rating Scale (HAM-D) score, Brief Psychiatric Rating Scale (BPRS) score, Young Mania Rating Scale (YMRS) score, Snaith-Hamilton Pleasure Scale (SHAPS) scores for anhedonia, Columbia–Suicide Severity Rating Scale and Beck Hopelessness Scale scores for suicide risk, Trail Making Test for attention and executive functions, Clinical Global Impression Severity (CGIS) and Health Status Questionnaire scores for impact of symptoms on health, Functional magnetic resonance imaging (fMRI) analysis for changes in connectivity patterns in TRD-related brain networks, Electroencephalography (EEG) for changes in functional connectivity | — |
Countries
Italy
Outcome results
None listed