Overview

Mirtazapine in Cancer-related Poly-symptomatology

Status:
Not yet recruiting
Trial end date:
2023-05-08
Target enrollment:
Participant gender:
Summary
Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.
Phase:
Phase 3
Details
Lead Sponsor:
Hospices Civils de Lyon
Treatments:
Citalopram
Mirtazapine