Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode

Depression Clinical Trial

— LABCATTCJUSS  

Official title:

Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02532660
• Other study ID #: Laboratório Catarinense Ltda
• Status: Terminated
• Phase: Phase 3
• Start date: July 2, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Laboratório Catarinense SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects from both sexes aged between 18 and 65 years;

• Patient diagnosed with mild depression episode confirmed by psychiatric and psychometric evaluation, presenting basal scores above 08 and below 24 measured by the Hamilton Rating Scale (HAM-D);

• Capable of understanding the nature and objective of the study, including risks and adverse effects and intended to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which comes to be confirmed by signing the informed consent.

Exclusion Criteria:

• Have a known hypersensitivity to Trichilia catigua or history of serious adverse reactions;

• Shows risk of suicide, assault, murder or moral exposure;

• Clinical history of bleeding disorders;

• Drug addiction, including alcohol;

• Known or suspected neoplasia;

• Knowledge positive test result for the human immunodeficiency virus;

• Patient not willing to adhere to the procedures of the Protocol;

• For women, can not be pregnant or nursing and must be in use of a contraception method during the participation in the study;

• Patients using other drugs with sedative or antidepressant action, which can not be suspended for 15 days (wash out);

• Diabetics;

• Hyperthyroidism;

• Participation in any experimental study or use of any experimental drug three months before the start of this study;

• Has any condition which the investigator deems relevant to the non-participation of the study.

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Escitalopram 10mg
Escitalopram 10mg (1 pill once a day)
• LABCAT TCJUSS
LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night)
• LABCAT TCJUSS Placebo
LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
• Escitalopram Placebo
Escitalopram Placebo (1 pill once a day)

Locations

Country	Name	City	State
Brazil	Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)	Fortaleza	Ceará

Sponsors (3)

Lead Sponsor	Collaborator
Laboratório Catarinense SA	Financiadora de Estudos e Projetos, Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D SCORE REDUCTION	A comparison will be performed between groups in mean reduction in the HAM-D score between baseline (V1-D1) and at weeks 2 (V2), 4 (V3), 8 (V4) and 10 (V5) treatment, following the primary and secondary described outcomes.	WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Secondary	Evaluation of symptoms of anhedonia by the change in mean score of Shaps-C scale of pleasure		WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Secondary	Change in mean scores of Clinical Global Impression performed by the investigator (CGI-I - Improvement)		WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Secondary	Change in mean scores of Clinical Global Impression performed by the investigator (CGI-S - Severity)		WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Secondary	Change in mean scores of Global Patient Evaluation scale		WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Secondary	Change in mean scores of the of Arizona Sexual Experiences scale (ASEX)		WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)