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

NCT02532660 | Terminated Phase 3

• 1 other identifier: Laboratório Catarinense Ltda
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (3)

Escitalopram + LABCAT TCJUSS

EXPERIMENTAL

Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);

Drug: Escitalopram 10mg; Drug: LABCAT TCJUSS

Escitalopram + LABCAT TCJUSS placebo

PLACEBO COMPARATOR

Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);

Drug: Escitalopram 10mg; Drug: LABCAT TCJUSS Placebo

Escitalopram Placebo + LABCAT TCJUSS

EXPERIMENTAL

Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).

Drug: LABCAT TCJUSS; Drug: Escitalopram Placebo

Interventions

Escitalopram 10mg DRUG

Escitalopram 10mg (1 pill once a day)

Escitalopram + LABCAT TCJUSS; Escitalopram + LABCAT TCJUSS placebo

LABCAT TCJUSS DRUG

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

Escitalopram + LABCAT TCJUSS; Escitalopram Placebo + LABCAT TCJUSS

LABCAT TCJUSS Placebo DRUG

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

Escitalopram + LABCAT TCJUSS placebo

Escitalopram Placebo DRUG

Escitalopram Placebo (1 pill once a day)

Escitalopram Placebo + LABCAT TCJUSS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratório Catarinense SA: lead
• Universidade Federal do Ceara: collaborator
• Financiadora de Estudos e Projetos: collaborator

Study Sites (1)

Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)

Fortaleza, Ceará, 60430-275, Brazil

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Maria Elisabete Moraes

  Universidade Federal do Ceara (UFC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 26, 2015
• Study Start: July 2, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

BR (1)