The effect of using medication for pain (Tramadol) in a Depressed patient

Not Applicable

Recruiting

• Conditions: F00-F99; Severe depressive episode without psychotic symptoms

• Registration Number: RBR-2qcjbf
• Lead Sponsor: Hospital das Clínicas de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-06
• Study Completion: 2022-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To verify the efficacy of tramadol as an adjunct to the usual pharmacological treatment in the remission of suicidal ideation (secondary outcome);<br><br>; 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.