Treatment Resistant Depression
Conditions
Keywords
Psychotherapy, Treatment Resistant Depression, depression
Brief summary
The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.
Interventions
OTHERIPT+ antidepressant drugs
16 sessions of interpersonal psychotherapy plus antidepressant drugs.
DRUGfluoxetine
Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed
DRUGsertraline
DRUGparoxetine
DRUGCitalopram
DRUGescitalopram
DRUGfluvoxamine
DRUGVenlafaxine
DRUGDuloxetine
DRUGBupropion
DRUGLithium
DRUGRisperidone
DRUGtranylcypromine
DRUGImipramine
DRUGamitriptyline
DRUGClomipramine
DRUGnortriptyline
DRUGtrazodone
DRUGMirtazapine
DRUGsulpiride
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary diagnose of unipolar treatment resistant depression
Exclusion criteria
* Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence. * Currently in or having received psychotherapy in the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale (HAM-D) - continuous | End point week 19 and Week 24 | Score change on Hamilton depression scale from baseline to week 19 and to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck depression Inventory (BDI) | End point week 19 and Week 24 | Score change on Beck depression inventory from baseline to week 19 and to week 24 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Severity Scale (CGI-S) / dichotomous | Endpoint (week-19) and week 24 | — |
| Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version | Endpoint week 19 and week 24 | Score change in Whoqol-breef from baseline to week 19 and week 24 |
| Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6 | End point week 19 and Week 24 | A blood sample will be collected at baseline, week 19 and week 24. Change in serum biomarkers will be evaluated - BDFN (Brain derived neurotrophic factor), TBARS (thiobarbituric acid reactive substance), TNF-alfa (tumor necrosis factor alfa), IL-1 (interleukin-1), IL-6 (interlekin-6) before and after treatment. |
Countries
Brazil
Contacts
Primary ContactLivia H Souza, MD
Backup ContactMarcelo PA Fleck, PhD
Outcome results
None listed