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

Phase 3

Terminated

• Conditions: Depression
• Interventions: Drug: Escitalopram 10mg; Drug: LABCAT TCJUSS; Drug: LABCAT TCJUSS Placebo; Drug: Escitalopram Placebo

• Registration Number: NCT02532660
• Lead Sponsor: Laboratório Catarinense SA

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

Study Timeline

• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-26
• Study Start: 2018-07-02
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram + LABCAT TCJUSS	Escitalopram 10mg	Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);
Escitalopram + LABCAT TCJUSS	LABCAT TCJUSS	Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);
Escitalopram + LABCAT TCJUSS placebo	Escitalopram 10mg	Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
Escitalopram + LABCAT TCJUSS placebo	LABCAT TCJUSS Placebo	Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
Escitalopram Placebo + LABCAT TCJUSS	LABCAT TCJUSS	Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).
Escitalopram Placebo + LABCAT TCJUSS	Escitalopram Placebo	Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).

Primary Outcome Measures

Name	Time	Method
HAM-D SCORE REDUCTION	WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)	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.

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
Change in mean scores of Global Patient Evaluation scale	WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
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)

Trial Locations

Locations (1)

Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará); 🇧🇷 Fortaleza, Ceará, Brazil