Clinical trial NCT02532660: Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
Official title: Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depression
Lead sponsor: Laboratório Catarinense SA
Sponsor class: INDUSTRY
Collaborators: name: Universidade Federal do Ceara
name: Financiadora de Estudos e Projetos
First posted: 2015-08-26
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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

Eligibility 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.

Primary outcomes:
measure: HAM-D SCORE REDUCTION
timeFrame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Secondary outcomes:
measure: Evaluation of symptoms of anhedonia by the change in mean score of Shaps-C scale of pleasure
timeFrame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
measure: Change in mean scores of Clinical Global Impression performed by the investigator (CGI-I - Improvement)
timeFrame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
measure: Change in mean scores of Clinical Global Impression performed by the investigator (CGI-S - Severity)
timeFrame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
measure: Change in mean scores of Global Patient Evaluation scale
timeFrame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
measure: Change in mean scores of the of Arizona Sexual Experiences scale (ASEX)
timeFrame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)
state: Ceará
Study officials:
affiliation: Universidade Federal do Ceara (UFC)
name: Maria Elisabete Moraes
role: PRINCIPAL_INVESTIGATOR
References: