depression Major Depressive Disorder
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Moderate or severe diagnosis of MDD - based on a structured clinical interview (MINI) - score of >20 on the MADRS score, and in need of pharmacological treatment with AD according to their physician and existing guide-lines. - Free of psychotropic medications for at least 5 half-lives (e.g. 1 week for most antidepressants, 5 weeks for fluoxetine) at baseline. - Fluency in Dutch, sufficient to complete the interviews and self-report questionnaires.
Exclusion criteria
Exclusion criteria: - IQ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response or non-response. In accordance with the CAN-BIND study7, response is defined as a greater than 50% reduction in MADRS score8 at week 8 when compared to baseline. Success of the DEPREDICT algorithm to predict treatment response will be judged based on the calculated sensitivity/specificity of the algorithm (which is based on both baseline-, and/or the 2 week MRI scan, as well as clinical variables and information on sleep and activity) to predict clinical outcome (MADRS-non-response). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Response to treatment as a score of 1 or 2 on the Clinical Global Impression Scale (CGI) improvement item (indicating *very much improved *or *much improved*) at week 8. Partial response is defined as a score of 3 on the improvement item. Worsening of depression is defined as a CGI improvement item score of 5, 6, or 7 at week 8. - Inventory of Depressive Symptomatology - Self Rated (IDS-SR) - Morisky questionnaire for medication adherence - Self-reported anhedonia using the Dimensional Anhedonia Rating Scale (DARS) | — |
Countries
Netherlands
Outcome results
None listed