Pharmacological and non Treatment for resistant depressio

Phase 1

• Conditions: on-responders with Treatment Resistant Depression; MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004169-28-IT
• Lead Sponsor: I.R.C.C.S. FONDAZIONE S.LUCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 639

Inclusion Criteria

All depression patient will have to show a current depressive episode of at least 12 weeks as assessed by a clinical evaluation including the MADRS that will have a score less than 20 at screening and at baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects whit any history of bipolar disorders or psychosis (diagnosed by MINI), with suicidal ideation and unstable medical issues will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified