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

Sponsor

Laboratório Catarinense SA (Industry)

Overall Status

Terminated

CT.gov ID

NCT02532660

Collaborator

Universidade Federal do Ceara (Other), Financiadora de Estudos e Projetos (Other)

111

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Escitalopram 10mg Drug: LABCAT TCJUSS Drug: LABCAT TCJUSS Placebo Drug: Escitalopram Placebo	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 2, 2018

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Escitalopram + LABCAT TCJUSS Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);	Drug: Escitalopram 10mg Escitalopram 10mg (1 pill once a day) Drug: LABCAT TCJUSS LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night)
Placebo Comparator: Escitalopram + LABCAT TCJUSS placebo Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);	Drug: Escitalopram 10mg Escitalopram 10mg (1 pill once a day) Drug: LABCAT TCJUSS Placebo LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
Experimental: Escitalopram Placebo + LABCAT TCJUSS Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).	Drug: LABCAT TCJUSS LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night) Drug: Escitalopram Placebo Escitalopram Placebo (1 pill once a day)

Arm

Intervention/Treatment

Experimental: Escitalopram + LABCAT TCJUSS

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

Drug: Escitalopram 10mg

Escitalopram 10mg (1 pill once a day)

Drug: LABCAT TCJUSS

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

Placebo Comparator: Escitalopram + LABCAT TCJUSS placebo

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

Drug: Escitalopram 10mg

Escitalopram 10mg (1 pill once a day)

Drug: LABCAT TCJUSS Placebo

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

Experimental: Escitalopram Placebo + LABCAT TCJUSS

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

Drug: LABCAT TCJUSS

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

Drug: Escitalopram Placebo

Escitalopram Placebo (1 pill once a day)

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)	Fortaleza	Ceará	Brazil	60430-275

Sponsors and Collaborators

Laboratório Catarinense SA
Universidade Federal do Ceara
Financiadora de Estudos e Projetos

Investigators

Principal Investigator: Maria Elisabete Moraes, Universidade Federal do Ceara (UFC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laboratório Catarinense SA

ClinicalTrials.gov Identifier:

NCT02532660

Other Study ID Numbers:

Laboratório Catarinense Ltda

First Posted:

Aug 26, 2015

Last Update Posted:

Jun 16, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Dexetimide

Citalopram

Study Results

No Results Posted as of Jun 16, 2022