Chronic PainCANAREALNCT07362407
Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study
An observational study of Chronic Pain and Depression Disorders, run by Santa Catarina Federal University at 1 site in Brazil.
Trial summary
What is the purpose of this study? The use of medicinal cannabis has grown significantly in Brazil. However, because many patients use these products through "compassionate use" (when traditional treatments haven't worked), there is still a lack of large-scale data on how these treatments perform in daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Depression Disorders, Anxiety Disorders
- What is being tested?
- Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes.
- How many people
- 384 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study targets a diverse population of patients in Brazil who seek cannabinoid therapy for various medical conditions, primarily chronic pain, anxiety, and depression, through the pharmaceutical and clinical service flow of partner companies and clinics.
Who may be able to join
- Patients aged 18 years or older.
- Residents of Brazil.
- Patients who have a valid medical prescription for cannabis-based products.
- Patients who are either starting a new treatment or are already using cannabinoid products under the ANVISA RDC 660/22 or RDC 327/19 regulations.
- Capability to understand and sign the Informed Consent Form (ICF).
- Access to a smartphone or computer with internet to complete the digital follow-up questionnaires.
Who cannot join
- Patients who do not agree to the terms of the Informed Consent Form (ICF).
- Patients who fail to complete the initial (Baseline/T0) sociodemographic and clinical questionnaires.
- Inability to communicate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Federal de Santa Catarina (UFSC), Centro de Ciências Biológicas (CCB), Campus Universitário, Trindade, Florianópolis - SC.
Florianópolis, Santa Catarina, 88049-900
About this study
Official title: Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study (CANAREAL)
What is the purpose of this study? The use of medicinal cannabis has grown significantly in Brazil. However, because many patients use these products through "compassionate use" (when traditional treatments haven't worked), there is still a lack of large-scale data on how these treatments perform in daily life. This study, called CANAREAL, aims to track patients across Brazil to understand if cannabis-based products are truly effective and safe for treating various conditions, such as chronic pain, anxiety, and depression.
How will the study work? This is an observational study, which means the researchers will not provide the medication or change the treatment prescribed by the patient's doctor. Instead, we will simply "follow" the patient's journey for 6 months.
Read more
What will participants be asked to do? Participants will complete online questionnaires at different stages of their treatment. These tools will measure:
Quality of Life: How the treatment affects daily well-being.
Clinical Evolution: Changes in pain levels, anxiety, and depression symptoms.
Safety: Whether the patient experiences any side effects (adverse events).
Why is this study important? Unlike controlled laboratory tests, this "Real-World Study" captures the reality of diverse patients with different backgrounds and health needs. The information gathered will help doctors, patients, and health authorities in Brazil better understand the benefits and risks of cannabinoid therapy, leading to safer and more informed medical decisions in the future.
Read the detailed description
Study Rationale and Context The CANAREAL study is designed as a prospective, longitudinal, observational investigation aimed at filling the gap between controlled clinical trials and the clinical reality of medicinal cannabis use in Brazil. Under current Brazilian regulations (RDC 327/2019 and RDC 660/2022), patients access cannabinoid-based products primarily through compassionate use. This study adopts a Real-World Evidence (RWE) approach to evaluate how these treatments perform across a heterogeneous population with various comorbidities and treatment regimens.
Study Design and Procedures Participants who have already been prescribed cannabis-based products by their physicians will be recruited. The study does not interfere with medical prescriptions, dosages, or product choices.
Data collection will be conducted at three specific time points over a 180-day (6-month) period:
Baseline (T0): Collection of demographic data, medical history, primary reason for cannabis use, and previous conventional treatments. Initial scores for pain, anxiety, depression, and quality of life will be recorded.
Intermediate Follow-up (T1 - 90 days): Assessment of clinical evolution and monitoring of any early adverse events.
Final Assessment (T2 - 180 days): Final evaluation of therapeutic efficacy and overall impact on the patient's quality of life.
Instruments and Measurements To ensure objective quantification of subjective symptoms, the following validated psychometric and clinical tools will be utilized:
Quality of Life: The WHOQOL-Bref (World Health Organization Quality of Life) and EUROQOL-5D scales.
Clinical Symptomatology: The Visual Analogue Scale (VAS) for pain intensity, the Beck Depression Inventory (BDI), and the Beck Anxiety Inventory (BAI).
Safety Profile: The UKU Side Effect Rating Scale will be used to document the frequency, severity, and nature of adverse drug reactions (ADRs).
Data Management and Analysis Data will be collected via secure digital platforms (Google Forms/WhatsApp). Statistical analysis will include descriptive statistics for demographic characterization and inferential analysis (e.g., paired t-tests or non-parametric equivalents) to compare baseline scores against the 3-month and 6-month follow-ups. The study intends to identify patterns of efficacy based on the cannabinoid profile (CBD-dominant, THC-dominant, or balanced) and the specific medical conditions treated.
Ethical Compliance The study is conducted in accordance with the Declaration of Helsinki and submitted for approval by the Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC). All participants must provide electronic Informed Consent (ICF) before data collection begins.
- Conditions
- Chronic Pain, Depression Disorders, Anxiety Disorders, Quality of Life, Cannabidiol Effects, Cannabinoids
- Being tested
- Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes.
- Keywords
- cannabis, cannabinoids, medical cannabis, Real-Word Evidence, Quality of life, observational study, cbd, thc, brazil, chronic pain
- Medical subject headings
- Chronic Pain, Anxiety Disorders, Marijuana Abuse, Color Vision Defects, Wiskott-Aldrich Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes.Dietary supplement
Also called Cannabis-based products, Phytocannabinoids, CBD oil, medical marijuana
This is an observational study of patients using cannabis-based products as prescribed by their personal physicians. The investigators do not provide, prescribe, or assign any medication. Participants will use various formulations (such as CBD-dominant, THC-dominant, or balanced full-spectrum oils) administered according to their specific medical guidance. Data collection will focus on the natural course of the treatment, monitoring clinical evolution, quality of life, and safety through validated scales over a 6-month period.
| Study group | Role | What they receive |
|---|---|---|
| Medicinal Cannabinoid Users | Patients who use or are starting treatment with cannabis-based products prescribed under Brazilian regulations (RDC 660/22). This group includes individuals seeking treatment for various clinical conditions, such as chronic pain, anxiety, and depression, through compassionate use. Receives: Dietary Supplement: Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life Scores
Evaluation of the patient's quality of life using the WHOQOL-Bref questionnaire (World Health Organization Quality of Life). This scale evaluates physical, psychological, social relationships, and environment domains. Scores range from 0 to 100, where higher scores indicate a better quality of life.
Measured: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Secondary outcomes (3)
Change in Pain Intensity
Assessment of pain using the Visual Analogue Scale (VAS). Patients report their pain level on a scale from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Change in Depression Severity
Measured by the Beck Depression Inventory (BDI). It consists of 21 items. Total scores range from 0 to 63, with higher scores indicating increased severity of depressive symptoms.
Measured: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Change in Anxiety Severity
Measured by the Beck Anxiety Inventory (BAI). It consists of 21 items. Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Santa Catarina Federal University
- Sponsor type
- University, hospital or other
- Collaborators
- HempMeds Brasil
- Responsible party
- Principal investigator, Taynara da Silva, Santa Catarina Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362407
- Sponsor's protocol ID
- CANAREAL-2025
- Other IDs
- 8.083.335
- Acronym
- CANAREAL
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) collected during the study will be shared in a de-identified format. Data access will be granted to researchers whose proposed use of the data has been formally approved by an independent review committee. The sharing process strictly complies with the Brazilian General Data Protection Law (LGPD). De-identified raw data concerning quality of life scores obtained through WHOQOL-Bref and EUROQOL-5D instruments. Clinical evolution scores for pain (Visual Analogue Scale - VAS), anxiety (Beck Anxiety Inventory - BAI), and depression (Beck Depression Inventory - BDI). Reported adverse events collected via the UKU Side Effect Rating Scale.
Publications
Pertwee RG. The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin. Br J Pharmacol. 2008 Jan;153(2):199-215. doi: 10.1038/sj.bjp.0707442. Epub 2007 Sep 10.
PubMed 17828291Cristino L, Bisogno T, Di Marzo V. Cannabinoids and the expanded endocannabinoid system in neurological disorders. Nat Rev Neurol. 2020 Jan;16(1):9-29. doi: 10.1038/s41582-019-0284-z. Epub 2019 Dec 12.
PubMed 31831863Maccarrone M, Di Marzo V, Gertsch J, Grether U, Howlett AC, Hua T, Makriyannis A, Piomelli D, Ueda N, van der Stelt M. Goods and Bads of the Endocannabinoid System as a Therapeutic Target: Lessons Learned after 30 Years. Pharmacol Rev. 2023 Sep;75(5):885-958. doi: 10.1124/pharmrev.122.000600. Epub 2023 May 10.
PubMed 37164640Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
PubMed 3785962Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
PubMed 10881154Bhatt A. Conducting real-world evidence studies in India. Perspect Clin Res. 2019 Apr-Jun;10(2):51-56. doi: 10.4103/picr.PICR_8_19.
PubMed 31008069Kim HS, Lee S, Kim JH. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci. 2018 Jun 26;33(34):e213. doi: 10.3346/jkms.2018.33.e213. eCollection 2018 Aug 20.
PubMed 30127705Chodankar D. Introduction to real-world evidence studies. Perspect Clin Res. 2021 Jul-Sep;12(3):171-174. doi: 10.4103/picr.picr_62_21. Epub 2021 Jul 7. No abstract available.
PubMed 34386383
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study (CANAREAL)
- ClinicalTrials.gov ID
- NCT07362407
- Acronym / sponsor ID
- CANAREAL / CANAREAL-2025
- Conditions
- Chronic Pain, Depression Disorders, Anxiety Disorders, Quality of Life, Cannabidiol Effects, Cannabinoids
- Keywords
- cannabis, cannabinoids, medical cannabis, Real-Word Evidence, Quality of life, observational study, cbd, thc
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Santa Catarina Federal UniversityUniversity, hospital or other
- Collaborators
- HempMeds Brasil
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- 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.
What is the purpose of this study? The use of medicinal cannabis has grown significantly in Brazil. However, because many patients use these products through "compassionate use" (when traditional treatments haven't worked), there is still a lack of large-scale data on how these treatments perform in daily life. This study, called CANAREAL, aims to track patients across Brazil to understand if cannabis-based products are truly effective and safe for treating various conditions, such as chronic pain, anxiety, and depression.
How will the study work? This is an observational study, which means the researchers will not provide the medication or change the treatment prescribed by the patient's doctor. Instead, we will simply "follow" the patient's journey for 6 months.
What will participants be asked to do? Participants will complete online questionnaires at different stages of their treatment. These tools will measure:
Quality of Life: How the treatment affects daily well-being.
Clinical Evolution: Changes in pain levels, anxiety, and depression symptoms.
Safety: Whether the patient experiences any side effects (adverse events).
Why is this study important? Unlike controlled laboratory tests, this "Real-World Study" captures the reality of diverse patients with different backgrounds and health needs. The information gathered will help doctors, patients, and health authorities in Brazil better understand the benefits and risks of cannabinoid therapy, leading to safer and more informed medical decisions in the future.
Detailed description
Study Rationale and Context The CANAREAL study is designed as a prospective, longitudinal, observational investigation aimed at filling the gap between controlled clinical trials and the clinical reality of medicinal cannabis use in Brazil. Under current Brazilian regulations (RDC 327/2019 and RDC 660/2022), patients access cannabinoid-based products primarily through compassionate use. This study adopts a Real-World Evidence (RWE) approach to evaluate how these treatments perform across a heterogeneous population with various comorbidities and treatment regimens.
Study Design and Procedures Participants who have already been prescribed cannabis-based products by their physicians will be recruited. The study does not interfere with medical prescriptions, dosages, or product choices.
Data collection will be conducted at three specific time points over a 180-day (6-month) period:
Baseline (T0): Collection of demographic data, medical history, primary reason for cannabis use, and previous conventional treatments. Initial scores for pain, anxiety, depression, and quality of life will be recorded.
Intermediate Follow-up (T1 - 90 days): Assessment of clinical evolution and monitoring of any early adverse events.
Final Assessment (T2 - 180 days): Final evaluation of therapeutic efficacy and overall impact on the patient's quality of life.
Instruments and Measurements To ensure objective quantification of subjective symptoms, the following validated psychometric and clinical tools will be utilized:
Quality of Life: The WHOQOL-Bref (World Health Organization Quality of Life) and EUROQOL-5D scales.
Clinical Symptomatology: The Visual Analogue Scale (VAS) for pain intensity, the Beck Depression Inventory (BDI), and the Beck Anxiety Inventory (BAI).
Safety Profile: The UKU Side Effect Rating Scale will be used to document the frequency, severity, and nature of adverse drug reactions (ADRs).
Data Management and Analysis Data will be collected via secure digital platforms (Google Forms/WhatsApp). Statistical analysis will include descriptive statistics for demographic characterization and inferential analysis (e.g., paired t-tests or non-parametric equivalents) to compare baseline scores against the 3-month and 6-month follow-ups. The study intends to identify patterns of efficacy based on the cannabinoid profile (CBD-dominant, THC-dominant, or balanced) and the specific medical conditions treated.
Ethical Compliance The study is conducted in accordance with the Declaration of Helsinki and submitted for approval by the Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC). All participants must provide electronic Informed Consent (ICF) before data collection begins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medicinal Cannabinoid Users | – | Dietary Supplement: Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes.Patients who use or are starting treatment with cannabis-based products prescribed under Brazilian regulations (RDC 660/22). This group includes individuals seeking treatment for various clinical conditions, such as chronic pain, anxiety, and depression, through compassionate use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study targets a diverse population of patients in Brazil who seek cannabinoid therapy for various medical conditions, primarily chronic pain, anxiety, and depression, through the pharmaceutical and clinical service flow of partner companies and clinics.
Key inclusion criteria (6 listed)
- Patients aged 18 years or older.
- Residents of Brazil.
- Patients who have a valid medical prescription for cannabis-based products.
- Patients who are either starting a new treatment or are already using cannabinoid products under the ANVISA RDC 660/22 or RDC 327/19 regulations.
- Capability to understand and sign the Informed Consent Form (ICF).
Key exclusion criteria (3 listed)
- Patients who do not agree to the terms of the Informed Consent Form (ICF).
- Patients who fail to complete the initial (Baseline/T0) sociodemographic and clinical questionnaires.
- Inability to communicate.
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 |
|---|---|---|
| Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes.Also: Cannabis-based products, Phytocannabinoids, CBD oil, medical marijuanaThis is an observational study of patients using cannabis-based products as prescribed by their personal physicians. The investigators do not provide, prescribe, or assign any medication. Participants will use various formulations (such as CBD-dominant, THC-dominant, or balanced full-spectrum oils) administered according to their specific medical guidance. Data collection will focus on the natural course of the treatment, monitoring clinical evolution, quality of life, and safety through validated scales over a 6-month period. | Dietary supplement | Medicinal Cannabinoid Users |
Primary outcome
Change in Quality of Life Scores
Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Evaluation of the patient's quality of life using the WHOQOL-Bref questionnaire (World Health Organization Quality of Life). This scale evaluates physical, psychological, social relationships, and environment domains. Scores range from 0 to 100, where higher scores indicate a better quality of life.
3 secondary outcomes
Change in Pain Intensity
Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Change in Depression Severity
Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Change in Anxiety Severity
Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 17828291Pertwee RG. The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin. Br J Pharmacol. 2008 Jan;153(2):199-215. doi: 10.1038/sj.bjp.0707442. Epub 2007 Sep 10.
- Background: PubMed 31831863Cristino L, Bisogno T, Di Marzo V. Cannabinoids and the expanded endocannabinoid system in neurological disorders. Nat Rev Neurol. 2020 Jan;16(1):9-29. doi: 10.1038/s41582-019-0284-z. Epub 2019 Dec 12.
- Background: PubMed 37164640Maccarrone M, Di Marzo V, Gertsch J, Grether U, Howlett AC, Hua T, Makriyannis A, Piomelli D, Ueda N, van der Stelt M. Goods and Bads of the Endocannabinoid System as a Therapeutic Target: Lessons Learned after 30 Years. Pharmacol Rev. 2023 Sep;75(5):885-958. doi: 10.1124/pharmrev.122.000600. Epub 2023 May 10.
- Background: PubMed 3785962Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
- Background: PubMed 10881154Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
- Background: PubMed 31008069Bhatt A. Conducting real-world evidence studies in India. Perspect Clin Res. 2019 Apr-Jun;10(2):51-56. doi: 10.4103/picr.PICR_8_19.
- Background: PubMed 30127705Kim HS, Lee S, Kim JH. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci. 2018 Jun 26;33(34):e213. doi: 10.3346/jkms.2018.33.e213. eCollection 2018 Aug 20.
- Background: PubMed 34386383Chodankar D. Introduction to real-world evidence studies. Perspect Clin Res. 2021 Jul-Sep;12(3):171-174. doi: 10.4103/picr.picr_62_21. Epub 2021 Jul 7. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) collected during the study will be shared in a de-identified format. Data access will be granted to researchers whose proposed use of the data has been formally approved by an independent review committee. The sharing process strictly complies with the Brazilian General Data Protection Law (LGPD). De-identified raw data concerning quality of life scores obtained through WHOQOL-Bref and EUROQOL-5D instruments. Clinical evolution scores for pain (Visual Analogue Scale - VAS), anxiety (Beck Anxiety Inventory - BAI), and depression (Beck Depression Inventory - BDI). Reported adverse events collected via the UKU Side Effect Rating Scale.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Depression Disorders, run by Santa Catarina Federal University 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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in Quality of Life Scores (time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07362407, which also lists 8 linked publications.
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 30 Mar 2026.