DepressionPhase 3LABCATTCJUSSNCT02532660
Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
A Phase 3 study testing Escitalopram 10mg and LABCAT TCJUSS in people with Depression, run by Laboratório Catarinense SA at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram 10mg and LABCAT TCJUSS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jul 2018to 1 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade de Farmacologia Clínica (UNIFAC - Universidade Federal do Ceará)
Fortaleza, Ceará, 60430-275
About this study
Official title: 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).
Read the detailed description
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
- Conditions
- Depression
- Being tested
- Escitalopram 10mg, LABCAT TCJUSS, LABCAT TCJUSS Placebo, Escitalopram Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 10mgDrug
Escitalopram 10mg (1 pill once a day)
LABCAT TCJUSSDrug
LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night)
LABCAT TCJUSS PlaceboDrug
LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
Escitalopram PlaceboDrug
Escitalopram Placebo (1 pill once a day)
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram + LABCAT TCJUSS | Experimental | Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night); Receives: 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); Receives: 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). Receives: Drug: LABCAT TCJUSS; Drug: Escitalopram Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Change in mean scores of Global Patient Evaluation scale
Measured: 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)
Measured: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start2 Jul 2018
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Recruitment difficulties due to monocentric study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratório Catarinense SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal do Ceara, Financiadora de Estudos e Projetos
- Responsible party
- Sponsor
- Investigators
- Maria Elisabete Moraes, Principal investigator, Universidade Federal do Ceara (UFC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532660
- Sponsor's protocol ID
- Laboratório Catarinense Ltda
- Acronym
- LABCATTCJUSS
- Status last verified
- Jun 2022
- First submitted
- 23 Aug 2015
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
- ClinicalTrials.gov ID
- NCT02532660
- Acronym / sponsor ID
- LABCATTCJUSS / Laboratório Catarinense Ltda
- Conditions
- Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties due to monocentric study
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Laboratório Catarinense SAIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal do Ceara, Financiadora de Estudos e Projetos
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Escitalopram + LABCAT TCJUSS | Experimental | Drug: Escitalopram 10mg, Drug: LABCAT TCJUSSEscitalopram 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 | Drug: Escitalopram 10mg, Drug: LABCAT TCJUSS PlaceboEscitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night); |
| Escitalopram Placebo + LABCAT TCJUSS | Experimental | Drug: LABCAT TCJUSS, Drug: Escitalopram PlaceboEscitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram 10mgEscitalopram 10mg (1 pill once a day) | Drug | Escitalopram + LABCAT TCJUSS, Escitalopram + LABCAT TCJUSS placebo |
| LABCAT TCJUSSLABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night) | Drug | Escitalopram + LABCAT TCJUSS, Escitalopram Placebo + LABCAT TCJUSS |
| LABCAT TCJUSS PlaceboLABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night); | Drug | Escitalopram + LABCAT TCJUSS placebo |
| Escitalopram PlaceboEscitalopram Placebo (1 pill once a day) | Drug | Escitalopram Placebo + LABCAT TCJUSS |
Primary outcome
HAM-D SCORE REDUCTION
Time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
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.
5 secondary outcomes
Evaluation of symptoms of anhedonia by the change in mean score of Shaps-C scale of pleasure
Time frame: 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)
Time frame: 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)
Time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Change in mean scores of Global Patient Evaluation scale
Time frame: 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)
Time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
Results and safety
The study was stopped early (reason given: Recruitment difficulties due to monocentric study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elisabete Moraes principal investigator
Universidade Federal do Ceara (UFC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Escitalopram 10mg and LABCAT TCJUSS in people with Depression, run by Laboratório Catarinense SA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties due to monocentric study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAM-D SCORE REDUCTION (time frame: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.