Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04763135
Status:
TERMINATED
Last Update Posted:
2023-06-08
First Post:
2021-02-15
Brief Title:
Mirtazapine in Cancer-related Poly-symptomatology
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology MIR-P A Mixed-method Randomized Controlled Trial Protocol
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulties in recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIR-P
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002994-90 | EUDRACT_NUMBER | None | None |