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

Laboratório Catarinense

Status and phase: Terminated; Phase 3

Conditions: Depression

Treatments: Drug: Escitalopram 10mg; Drug: LABCAT TCJUSS Placebo; Drug: Escitalopram Placebo; Drug: LABCAT TCJUSS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02532660

Laboratório Catarinense Ltda

Details and patient eligibility

About

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).

Full 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

Enrollment: 111 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 3 patient groups, including a placebo group

Escitalopram + LABCAT TCJUSS

Experimental group

Description:

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

Treatment:

Drug: LABCAT TCJUSS

Drug: Escitalopram 10mg

Escitalopram + LABCAT TCJUSS placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Escitalopram 10mg

Drug: LABCAT TCJUSS Placebo

Escitalopram Placebo + LABCAT TCJUSS

Experimental group

Description:

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

Treatment:

Drug: LABCAT TCJUSS

Drug: Escitalopram Placebo