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

• Status: Recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratório Catarinense SA
• Collaborators: Financiadora de Estudos e Projetos; Universidade Federal do Ceara
• Treatments: Citalopram; Dexetimide

Criteria

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.