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Recruitment difficulties due to monocentric study
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| Name | Class |
|---|---|
| Universidade Federal do Ceara | OTHER |
| Financiadora de Estudos e Projetos | OTHER |
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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).
Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + LABCAT TCJUSS in the following aspects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram + LABCAT TCJUSS | Experimental | Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night); |
|
| Escitalopram + LABCAT TCJUSS placebo | Placebo Comparator | Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night); |
|
| Escitalopram Placebo + LABCAT TCJUSS | Experimental | Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram 10mg | Drug | Escitalopram 10mg (1 pill once a day) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Elisabete Moraes | Universidade Federal do Ceara (UFC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Farmacologia ClÃnica (UNIFAC - Universidade Federal do Ceará) | Fortaleza | Ceará | 60430-275 | Brazil |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| LABCAT TCJUSS | Drug | LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night) |
|
| LABCAT TCJUSS Placebo | Drug | LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night); |
|
| Escitalopram Placebo | Drug | Escitalopram Placebo (1 pill once a day) |
|
| 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) |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |