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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
111
Escitalopram 10mg (1 pill once a day)
LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night)
LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)
Fortaleza, Ceará, Brazil
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.
Time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Evaluation of symptoms of anhedonia by the change in mean score of Shaps-C scale of pleasure
Time frame: 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)
Time frame: 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)
Time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Change in mean scores of Global Patient Evaluation scale
Time frame: 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)
Time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
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Escitalopram Placebo (1 pill once a day)