Trial | NCT02532660  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    111
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:

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
Study Started
Jul 02
2018
Primary Completion
Jun 01
2022
Study Completion
Jun 01
2022
Last Update
Jun 16
2022

Drug Escitalopram 10mg

Escitalopram 10mg (1 pill once a day)

Drug LABCAT TCJUSS

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

Drug LABCAT TCJUSS Placebo

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

Drug Escitalopram Placebo

Escitalopram Placebo (1 pill once a day)

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).

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.
No Results Posted