Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-14 @ 9:31 PM
Study NCT ID:
NCT02532660
Status:
TERMINATED
Last Update Posted:
2022-06-16
First Post:
2015-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
Sponsor:
Laboratório Catarinense SA
Organization:
Study Overview
Official Title:
Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment difficulties due to monocentric study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LABCATTCJUSS
Brief Summary:
Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + Trichilia catigua Dry Extract (LABCAT TCJUSS) in the average alteration on depression score measured by the Hamilton Scale (HAM-D).
Detailed Description:
Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + LABCAT TCJUSS in the following aspects:
1. Alteration on the average score of anhedonia symptoms through the Shaps-C Scale;
2. Alteration of average scores of Global Clinical Impression carried out by the investigator (CGI-S e CGI-I);
3. Average scores of the Patient Global Evaluation
1. Alteration on the average score of anhedonia symptoms through the Shaps-C Scale;
2. Alteration of average scores of Global Clinical Impression carried out by the investigator (CGI-S e CGI-I);
3. Average scores of the Patient Global Evaluation
Study Oversight
Has Oversight DMC:
False
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?: