Major Depressive DisorderPhase 3INSTA-MDNCT05644301
INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder
A Phase 3 study testing Celecoxib and Minocyclin in people with Major Depressive Disorder and Inflammation, run by Universiteit Antwerpen at 3 sites in Belgium.
Trial summary
This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Inflammation
- What is being tested?
- Celecoxib and Minocyclin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesBelgium
- Study dates
- 21 Sep 2023to Sep 2026
- 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
- Male or female, 18-65 years inclusive.
- Able and willing to give informed consent and take oral medication.
- Physically healthy.
- Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).
- The current episode of depression has failed to remit to the current antidepressant treatment at the adequate dose (as defined in the Maudsley Prescribing guidelines). Relapse while taking an antidepressant is also considered a treatment failure.
- Tolerant to the current antidepressant and having no planned changes in their current therapy for the duration of the study.
- Stable on current treatment for a minimum of 4 weeks (6 weeks for fluoxetine) prior to baseline.
- If female and of childbearing age, willing to use adequate contraceptive precautions and willing to take a pregnancy test at baseline.
Who cannot join
- Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (< 4 weeks before screening, excl. nicotine and caffeine).
- Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).
- History of peptic ulcer disease or gastrointestinal (GI) bleeding.
- Having an acute infection or inflammatory bowel disorder.
- Current severe cardiovascular disease, congestive heart failure (NYHA-class II-IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery),
- Liver impairment (alanine aminotransferase > 2x upper limit, serum albumin < 25 g/l or Child-Pugh Score ≥ 10)
Show all 14Show fewer
- Renal impairment (creatinine clearance < 30 mL/min).
- Having received >14 days of tetracycline or non-steroidal anti-inflammatory medication within the previous 2 months, or having a history of sensitivity or intolerance to these classes of drugs.
- Chronic severe hypertension (systolic BP > 170 mmHg).
- Serology positive for hepatitis-B surface antigen, hepatitis-C antibodies or HIV antibodies.
- Received electroconvulsive therapy < 2 months prior to screening.
- Blood donation in 30 days prior to screening.
- Pregnancy or breastfeeding.
- Currently enrolled in an intervention study.
Trial locations and contacts
3 sites in 1 country.
Celine Wessa, MD contact
Belgium3 sites, 3 recruiting
- Recruiting
UZ Brussel
Brussels
Chris Baeken, PhD MD
- Recruiting
UPC Duffel
Duffel, Antwerpen, 2570
Manuel Morrens, manuel.morrens@uantwerpen.be
Tim Rietberg
- Recruiting
Katholiek Universiteit Leuven Campus Kortenberg
Leuven
Elfi Vergaelen, MD PhD
Emma Saillart
About this study
Official title: INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive
This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.
Read the detailed description
This project aims to repurpose two established anti-inflammatory compounds as adjuvant therapy for immune-mediated depression, in line with state-of-the-art research of the last 10 years. Immune-mediated depression represents a subtype which accounts for approximately 30% of depressive disorders. Patients with this immunosubtype are more likely to have a higher severity of depression, a lower quality of life and more somatic symptoms. Furthermore it is accompanied by a high incidence of treatment resistance. While their mechanisms of action completely differ from those of existing antidepressant treatment options, immunomodulatory drugs celecoxib and minocycline have proven their merit as add-on treatment in depressive episodes. They have been on the Belgian market for years and come with a known pharmacological and safety profile. Patient stratification at baseline based on inflammatory status will reveal which inflammatory subpopulation benefits most from each of the two investigated anti-inflammatory compounds. Additionally, our distinctive study design allows head-to-head comparison of both add-on therapies and will as such provide the last stepping stones towards clinical implementation of individualised treatment strategies in depression.
- Conditions
- Major Depressive Disorder, Inflammation
- Being tested
- Celecoxib, Minocyclin, Placebo
- Keywords
- Immunopsychiatry, Celecoxib, Minocyclin, Inflammation, Randomised Controlled Clinical Trial
- Medical subject headings
- Depressive Disorder, Major, Inflammation, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Oral capsule, 200 mg, twice daily, for 12 weeks
MinocyclinDrug
Oral capsule, 100 mg, twice daily, for 12 weeks
PlaceboDrug
Oral capsule, no active substance, twice daily, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Minocyclin + Treatment As Usual (TAU) | Active comparator | Not described Receives: Drug: Minocyclin |
| High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Celecoxib + Treatment As Usual (TAU) | Active comparator | Not described Receives: Drug: Celecoxib |
| High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Placebo + Treatment As Usual (TAU) | Placebo comparator | Not described Receives: Drug: Placebo |
| High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Minocyclin + Treatment As Usual (TAU) | Active comparator | Not described Receives: Drug: Minocyclin |
| High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Celecoxib + Treatment As Usual (TAU) | Active comparator | Not described Receives: Drug: Celecoxib |
| High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Placebo + Treatment As Usual (TAU) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptom severity (HDRS-17)
Change in severity of depression measured as the change in the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms) between baseline and endpoint
Measured: T0 -> T6 (12 weeks)
Remission rate of depression (HDRS-17)
Rates of remission measured as a score of ≤7 on the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms and scores 0-7 are considered as being normal) at endpoint
Measured: T0 -> T6 (12 weeks)
Secondary outcomes (11)
Change in depressive symptom severity (IDS-30SR)
Change in severity of depression measured as the change in the Inventory of Depressive Symptomatology - Self Report (IDS-SR; score is ranging from 0 to 84, higher scores indicate higher severity of depressive symptoms)
Measured: T0 -> T6 (12 weeks)
Response rate of depressive symptoms (HDRS-17)
Response rates of the depressive symptoms measured on the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms), with response being defined as a 50% reduction in HDRS-17-score from baseline and partial response as a 25% reduction.
Measured: T0 -> T6 (12 weeks)
Change in night-time sleep (PSQI)
Change in night-time sleep quality and/or quantity measured on the Pittsburgh Sleep Quality Index (PSQI; score is ranging from 0 to 21, higher scores indicate more sleep disturbances)
Measured: T0 -> T6 (12 weeks)
Change in anxiety (STAI)
Change in anxiety measured on the Stait Trait Anxiety Inventory-Self Report (STAI; score is ranging from 20 tot 80, higher scores indicate higher levels of anxiety intensity)
Measured: T0 -> T6 (12 weeks)
Change in core assessment of psychomotor change (CORE)
Change in the degree of psychomotor disturbance (which is as an integral component of melancholia) measured on the Core Assessment Of Psychomotor Change (CORE; score is ranging from 0-54, higher scores indicate higher levels of psychomotor disturbances)
Measured: T0 -> T6 (12 weeks)
Depressive symptom profiles (IDS-SR)
Profile of the depression measured on the Inventory of Depressive Symptomatology - Self Report (IDS-SR; score is ranging from 0 to 84, higher scores indicate higher severity of depressive symptoms)
Measured: T0 -> T6 (12 weeks)
Therapy compliance (MARS)
Therapy compliance measured on the Medication Adherence Scale (MARS; score is ranging from 0-10, higher scores indicate better medication adherence)
Measured: T0 -> T6 (12 weeks)
Adverse effects
Side effects measured with a questionnaire based on the list as used in the Antidepressant Side-Effect Checklist (ASEC-21) and the known side effects of Minocycline and Celecoxib
Measured: T0 -> T6 (12 weeks)
Metabolic blood markers
Cholesterol (mg/dl), High Density Lipoprotein (HDL) (mg/dl), Low Density Lipoprotein (LDL) (mg/dl), fasting glucose (mg/dl), triglycerides (mg/dl)
Measured: T0 -> T6 (12 weeks)
Other metabolic measures
Waist circumference (cm), height (cm) will be measured to calculate the BMI (kg/m^2)
Measured: T0 -> T6 (12 weeks)
Other metabolic measures
Weight (kg) will be measured to calculate the BMI (kg/m^2)
Measured: T0 -> T6 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start21 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven, Vrije Universiteit Brussel, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Manuel Morrens, Universiteit Antwerpen
- Investigators
- Manuel Morrens, MD PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644301
- Sponsor's protocol ID
- T001222N
- Acronym
- INSTA-MD
- Status last verified
- Oct 2024
- First submitted
- 24 Nov 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osimo EF, Baxter LJ, Lewis G, Jones PB, Khandaker GM. Prevalence of low-grade inflammation in depression: a systematic review and meta-analysis of CRP levels. Psychol Med. 2019 Sep;49(12):1958-1970. doi: 10.1017/S0033291719001454. Epub 2019 Jul 1.
PubMed 31258105Foley EM, Parkinson JT, Kappelmann N, Khandaker GM. Clinical phenotypes of depressed patients with evidence of inflammation and somatic symptoms. Compr Psychoneuroendocrinol. 2021 Aug 5;8:100079. doi: 10.1016/j.cpnec.2021.100079. eCollection 2021 Nov.
PubMed 34729541Carvalho LA, Torre JP, Papadopoulos AS, Poon L, Juruena MF, Markopoulou K, Cleare AJ, Pariante CM. Lack of clinical therapeutic benefit of antidepressants is associated overall activation of the inflammatory system. J Affect Disord. 2013 May 15;148(1):136-40. doi: 10.1016/j.jad.2012.10.036. Epub 2012 Nov 27.
PubMed 23200297Wessa C, Janssens J, Coppens V, El Abdellati K, Vergaelen E, van den Ameele S, Baeken C, Zeeuws D, Milaneschi Y, Lamers F, Penninx B, Claes S, Morrens M, De Picker L. Efficacy of inflammation-based stratification for add-on celecoxib or minocycline in major depressive disorder: Protocol of the INSTA-MD double-blind placebo-controlled randomised clinical trial. Brain Behav Immun Health. 2024 Sep 19;41:100871. doi: 10.1016/j.bbih.2024.100871. eCollection 2024 Nov.
PubMed 39350954
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive
- ClinicalTrials.gov ID
- NCT05644301
- Acronym / sponsor ID
- INSTA-MD / T001222N
- Conditions
- Major Depressive Disorder, Inflammation
- Keywords
- Immunopsychiatry, Celecoxib, Minocyclin, Inflammation, Randomised Controlled Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven, Vrije Universiteit Brussel, Amsterdam UMC, location VUmc
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Dec 2022 (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.
This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.
Detailed description
This project aims to repurpose two established anti-inflammatory compounds as adjuvant therapy for immune-mediated depression, in line with state-of-the-art research of the last 10 years. Immune-mediated depression represents a subtype which accounts for approximately 30% of depressive disorders. Patients with this immunosubtype are more likely to have a higher severity of depression, a lower quality of life and more somatic symptoms. Furthermore it is accompanied by a high incidence of treatment resistance. While their mechanisms of action completely differ from those of existing antidepressant treatment options, immunomodulatory drugs celecoxib and minocycline have proven their merit as add-on treatment in depressive episodes. They have been on the Belgian market for years and come with a known pharmacological and safety profile. Patient stratification at baseline based on inflammatory status will reveal which inflammatory subpopulation benefits most from each of the two investigated anti-inflammatory compounds. Additionally, our distinctive study design allows head-to-head comparison of both add-on therapies and will as such provide the last stepping stones towards clinical implementation of individualised treatment strategies in depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Minocyclin + Treatment As Usual (TAU) | Active comparator | Drug: Minocyclin |
| High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Celecoxib + Treatment As Usual (TAU) | Active comparator | Drug: Celecoxib |
| High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Placebo + Treatment As Usual (TAU) | Placebo comparator | Drug: Placebo |
| High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Minocyclin + Treatment As Usual (TAU) | Active comparator | Drug: Minocyclin |
| High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Celecoxib + Treatment As Usual (TAU) | Active comparator | Drug: Celecoxib |
| High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Placebo + Treatment As Usual (TAU) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18-65 years inclusive.
- Able and willing to give informed consent and take oral medication.
- Physically healthy.
- Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).
- The current episode of depression has failed to remit to the current antidepressant treatment at the adequate dose (as defined in the Maudsley Prescribing guidelines). Relapse while taking an antidepressant is also considered a treatment failure.
Key exclusion criteria (14 listed)
- Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (< 4 weeks before screening, excl. nicotine and caffeine).
- Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).
- History of peptic ulcer disease or gastrointestinal (GI) bleeding.
- Having an acute infection or inflammatory bowel disorder.
- Current severe cardiovascular disease, congestive heart failure (NYHA-class II-IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery),
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 |
|---|---|---|
| CelecoxibOral capsule, 200 mg, twice daily, for 12 weeks | Drug | High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Celecoxib + Treatment As Usual (TAU), High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Celecoxib + Treatment As Usual (TAU) |
| MinocyclinOral capsule, 100 mg, twice daily, for 12 weeks | Drug | High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Minocyclin + Treatment As Usual (TAU), High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Minocyclin + Treatment As Usual (TAU) |
| PlaceboOral capsule, no active substance, twice daily, for 12 weeks | Drug | High Sensitive C-reactive Protein (hs-CRP) < 3mg/L: Placebo + Treatment As Usual (TAU), High Sensitive C-reactive Protein (hs-CRP) > 3mg/L: Placebo + Treatment As Usual (TAU) |
Primary outcome
Change in depressive symptom severity (HDRS-17)
Time frame: T0 -> T6 (12 weeks)
Change in severity of depression measured as the change in the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms) between baseline and endpoint
Remission rate of depression (HDRS-17)
Time frame: T0 -> T6 (12 weeks)
Rates of remission measured as a score of ≤7 on the 17-point scale of the Hamilton Depression Rating Scale (HDRS-17; score is ranging from 0 to 52, higher scores indicate higher severity of depressive symptoms and scores 0-7 are considered as being normal) at endpoint
11 secondary outcomes
Change in depressive symptom severity (IDS-30SR)
Time frame: T0 -> T6 (12 weeks)
Response rate of depressive symptoms (HDRS-17)
Time frame: T0 -> T6 (12 weeks)
Change in night-time sleep (PSQI)
Time frame: T0 -> T6 (12 weeks)
Change in anxiety (STAI)
Time frame: T0 -> T6 (12 weeks)
Change in core assessment of psychomotor change (CORE)
Time frame: T0 -> T6 (12 weeks)
Depressive symptom profiles (IDS-SR)
Time frame: T0 -> T6 (12 weeks)
Therapy compliance (MARS)
Time frame: T0 -> T6 (12 weeks)
Adverse effects
Time frame: T0 -> T6 (12 weeks)
Metabolic blood markers
Time frame: T0 -> T6 (12 weeks)
Other metabolic measures
Time frame: T0 -> T6 (12 weeks)
Other metabolic measures
Time frame: T0 -> T6 (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 31258105Osimo EF, Baxter LJ, Lewis G, Jones PB, Khandaker GM. Prevalence of low-grade inflammation in depression: a systematic review and meta-analysis of CRP levels. Psychol Med. 2019 Sep;49(12):1958-1970. doi: 10.1017/S0033291719001454. Epub 2019 Jul 1.
- Background: PubMed 34729541Foley EM, Parkinson JT, Kappelmann N, Khandaker GM. Clinical phenotypes of depressed patients with evidence of inflammation and somatic symptoms. Compr Psychoneuroendocrinol. 2021 Aug 5;8:100079. doi: 10.1016/j.cpnec.2021.100079. eCollection 2021 Nov.
- Background: PubMed 23200297Carvalho LA, Torre JP, Papadopoulos AS, Poon L, Juruena MF, Markopoulou K, Cleare AJ, Pariante CM. Lack of clinical therapeutic benefit of antidepressants is associated overall activation of the inflammatory system. J Affect Disord. 2013 May 15;148(1):136-40. doi: 10.1016/j.jad.2012.10.036. Epub 2012 Nov 27.
- Derived from this study: PubMed 39350954Wessa C, Janssens J, Coppens V, El Abdellati K, Vergaelen E, van den Ameele S, Baeken C, Zeeuws D, Milaneschi Y, Lamers F, Penninx B, Claes S, Morrens M, De Picker L. Efficacy of inflammation-based stratification for add-on celecoxib or minocycline in major depressive disorder: Protocol of the INSTA-MD double-blind placebo-controlled randomised clinical trial. Brain Behav Immun Health. 2024 Sep 19;41:100871. doi: 10.1016/j.bbih.2024.100871. eCollection 2024 Nov.
- Individual participant dataSharing planned: No
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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.
Celine Wessa, MD contact
Manuel Morrens, MD PhD principal investigator
Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib and Minocyclin in people with Major Depressive Disorder and Inflammation, run by Universiteit Antwerpen at 3 sites in Belgium.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Janssens, MD (015304643, jonas.janssens@emmaus.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptom severity (HDRS-17) (time frame: T0 -> T6 (12 weeks)). The study lists 2 primary outcomes in all. 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 NCT05644301, which also lists 4 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 15 Oct 2024.