Severe depressive episode without psychotic symptoms
Conditions
Interventions
Administered Tramadol 50mg one oral capsule of 8/8 hours for 14 days this group will have 40 participants. The control group will also have 40 participants who will be given placebo an oral capsule of
D26.660
Sponsors
Hospital das Clínicas de Ribeirão Preto
Fundação de Amparo à Pesquisa do Estado de São Paulo
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis of Severe depressive episode without psychotic symptoms and score 17 or over of Hamilton Depression Rating Scale (HAM-D)
Exclusion criteria
Exclusion criteria: Diagnoses of bipolar affective disorder or previous manic episode; obsessive-compulsive disorder; eating disorder; patients with clinical use of antipsychotics; psychoactive substance use disorder; pregnant and lactating women; carriers of liver diseases; renal volume carriers (clearance <30); who are using medications with potential interaction with tramadol or with another serious medical illness: with comorbidities that affect the immune system, including autoimmune or comorbid disease (eg: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, etc.); recent consultation requiring antibiotics in the last month; chronic infections (human immunodeficiency virus, Hepatitis B and C); historic of cancer current or prehistoric, that are in use of medical communications in system of anti-inflammatory inflammatory (ex: glucocorticoids, non-steroidal anti-inflammatory agents). Also excluded from the study are patients who use antidepressants, antipsychotics or mood stabilizers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Check the efficacy of tramadol, as an adjunct to usual pharmacological treatment, to reduce the severity of depressive symptoms, as measured by the symptom severity scale, over a 12-week follow-up regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| To verify the efficacy of tramadol as an adjunct to the usual pharmacological treatment in the remission of suicidal ideation (secondary outcome); ; Check the association of the inflammatory profile (CRP, TNF-alfa, IL-6, IL-10, IL-17a and TGFbeta) with the severity of depression at the time of hospitalization and its role as a predictor of response to pharmacological treatment;;To verify the association of HHA axis reactivity with the severity of depression at the time of hospitalization and its role as a predictor of response to pharmacological treatment. | — |
Countries
Brazil
Contacts
Public ContactAndre Boin
Hospital das Clínicas de Ribeirão Preto
Outcome results
None listed