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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Depression

Intervention / Treatment
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* Drug: Escitalopram 10mg
* Drug: LABCAT TCJUSS
* Drug: LABCAT TCJUSS Placebo
* Drug: Escitalopram Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |