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

Primary Purpose

Depression

Status

Terminated

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Escitalopram 10mg

LABCAT TCJUSS

LABCAT TCJUSS Placebo

Escitalopram Placebo

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Escitalopram + LABCAT TCJUSS

Escitalopram + LABCAT TCJUSS placebo

Escitalopram Placebo + LABCAT TCJUSS

Arm Description

Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);

Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);

Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of symptoms of anhedonia by the change in mean score of Shaps-C scale of pleasure

Change in mean scores of Clinical Global Impression performed by the investigator (CGI-I - Improvement)

Change in mean scores of Clinical Global Impression performed by the investigator (CGI-S - Severity)

Change in mean scores of Global Patient Evaluation scale

Change in mean scores of the of Arizona Sexual Experiences scale (ASEX)

Full Information

NCT ID

NCT02532660

First Posted

August 23, 2015

Last Updated

June 13, 2022

Sponsor

Laboratório Catarinense SA

Collaborators

Universidade Federal do Ceara, Financiadora de Estudos e Projetos

1. Study Identification

Unique Protocol Identification Number

NCT02532660

Brief Title

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

Acronym

LABCATTCJUSS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Terminated

Why Stopped

Recruitment difficulties due to monocentric study

Study Start Date

July 2, 2018 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratório Catarinense SA

Collaborators

Universidade Federal do Ceara, Financiadora de Estudos e Projetos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: Alteration on the average score of anhedonia symptoms through the Shaps-C Scale; Alteration of average scores of Global Clinical Impression carried out by the investigator (CGI-S e CGI-I); Average scores of the Patient Global Evaluation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escitalopram + LABCAT TCJUSS

Arm Type

Experimental

Arm Description

Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);

Arm Title

Escitalopram + LABCAT TCJUSS placebo

Arm Type

Placebo Comparator

Arm Description

Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);

Arm Title

Escitalopram Placebo + LABCAT TCJUSS

Arm Type

Experimental

Arm Description

Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).

Intervention Type

Drug

Intervention Name(s)

Escitalopram 10mg

Intervention Description

Escitalopram 10mg (1 pill once a day)

Intervention Type

Drug

Intervention Name(s)

LABCAT TCJUSS

Intervention Description

LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night)

Intervention Type

Drug

Intervention Name(s)

LABCAT TCJUSS Placebo

Intervention Description

LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);

Intervention Type

Drug

Intervention Name(s)

Escitalopram Placebo

Intervention Description

Escitalopram Placebo (1 pill once a day)

Primary Outcome Measure Information:

Title

HAM-D SCORE REDUCTION

Description

Time Frame