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

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

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).

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Drug: Escitalopram 10mg; Drug: LABCAT TCJUSS; Drug: LABCAT TCJUSS Placebo; Drug: Escitalopram Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-275
      • Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Laboratório Catarinense SA
• Collaborators: Financiadora de Estudos e Projetos; Universidade Federal do Ceará
• Investigators: Principal Investigator: Maria Elisabete Moraes, Universidade Federal do Ceara (UFC)

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: August 23, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: Laboratório Catarinense Ltda

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No