Mood DisordersNCT06306248
Immune Activation, Neural Plasticity and Depression
An observational study of Mood Disorders and Major Depressive Disorder, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorders, Major Depressive Disorder, Sleep Deprivation
- What is being tested?
- Total sleep deprivation
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 3 Mar 2023to 9 May 2025
- Phase
- Observational
- 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
Study population: Patients diagnosed with major depressive disorder
Who may be able to join
- A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD with:
- HDRS score > 17
- Age 18-65 years;
- In treatment with TSD+LT
- Signed informed consent, able to understand, speak and write the national language
Who cannot join
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa;
- Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants
- Active infection requiring antibiotics therapy;
- Immunosuppressed patient or other chronic diseases
- Signs of active infection requiring treatment
- Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder. Forbidden treatment: corticosteroids, Non Steroidal Anti-inflammatory Drugs, immunosuppressant IV-Ig based treatment
Show all 17Show fewer
- Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II;
- Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
- Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial;
- Abuse of drugs or alcohol in the past 6 months Other exclusion criteria related to the MRI procedure include
- Aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker or auto-defibrillator
- Cochlear implant
- Ocular foreign body (e.g., metal shavings)
- Any implanted device (pumps, infusion devices, etc)
- Shrapnel injuries
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Mi, 20132
Sara SP Poletti, phd, 390226433156, poletti.sara@hsr.it
About this study
Official title: Adjusting Immune Activation to Reinstate Neural Plasticity and Promote the Beneficial Effect of Non-pharmacological Interventions
Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up.
- Conditions
- Mood Disorders, Major Depressive Disorder, Sleep Deprivation
- Being tested
- Total sleep deprivation
- Medical subject headings
- Mood Disorders, Depressive Disorder, Major, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total sleep deprivationOther
non pharmacologic treatment for depression
| Study group | Role | What they receive |
|---|---|---|
| MDD patients | 60 patients with a depressive episode in course of major depression (MDD) and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT).
Each subject will participate in the study for 6 months, will undergo MRI and clinical evaluation that will take overall about 2 hours at baseline (V0), after one week of chronobiological treatment and at 6 month follow-up. Receives: Other: Total sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients.
Response to total sleep deprivation will be measured (50% reduction in hamilton depression rating scale (HDRS), min score 0 max 52; higher scores higher severity of depression) in patients with C reactive protein levels <3 and >=3 mg/L.
Measured: at baseline, 1 week follow-up, 6 months follow up
Secondary outcomes (1)
Neurobiological markers of prediction and progression of antidepressant treatment
a machine learning algorithm will be implemented to identify markers of prediction of response to treatment (50% reduction in HDRS, min score 0 max 52; higher scores higher severity of depression) and disease progression (number of relapses and severity of depression at 6 months follow-up) based on changes in peripheral inflammatory markers and in brain measures of neural plasticity (e.g. brain levels of glutamate and GABA; measures of resting state functional connectivity: amplitude of low-frequency fluctuation, regional homogeneity) and structural integrity (e.g. brain volumes, white matter microstructure - fractional anisotropy).
Measured: from baseline to 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start3 Mar 2023
- Primary completion3 Mar 2025 (estimated)
- Study completion9 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Poletti, IRCCS Ospedale San Raffaele
- Investigators
- Sara Poletti, PhD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306248
- Sponsor's protocol ID
- PNRR-MAD-2022-12375716
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006 Jan;163(1):28-40. doi: 10.1176/appi.ajp.163.1.28.
PubMed 16390886Benedetti F, Dallaspezia S, Melloni EMT, Lorenzi C, Zanardi R, Barbini B, Colombo C. Effective Antidepressant Chronotherapeutics (Sleep Deprivation and Light Therapy) Normalize the IL-1beta:IL-1ra Ratio in Bipolar Depression. Front Physiol. 2021 Sep 1;12:740686. doi: 10.3389/fphys.2021.740686. eCollection 2021.
PubMed 34539454Miller AH, Raison CL. The role of inflammation in depression: from evolutionary imperative to modern treatment target. Nat Rev Immunol. 2016 Jan;16(1):22-34. doi: 10.1038/nri.2015.5.
PubMed 26711676Leboyer M, Berk M, Yolken RH, Tamouza R, Kupfer D, Groc L. Immuno-psychiatry: an agenda for clinical practice and innovative research. BMC Med. 2016 Oct 28;14(1):173. doi: 10.1186/s12916-016-0712-5.
PubMed 27788673Harrison NA, Brydon L, Walker C, Gray MA, Steptoe A, Critchley HD. Inflammation causes mood changes through alterations in subgenual cingulate activity and mesolimbic connectivity. Biol Psychiatry. 2009 Sep 1;66(5):407-14. doi: 10.1016/j.biopsych.2009.03.015. Epub 2009 May 7.
PubMed 19423079Hepgul N, Cattaneo A, Agarwal K, Baraldi S, Borsini A, Bufalino C, Forton DM, Mondelli V, Nikkheslat N, Lopizzo N, Riva MA, Russell A, Hotopf M, Pariante CM. Transcriptomics in Interferon-alpha-Treated Patients Identifies Inflammation-, Neuroplasticity- and Oxidative Stress-Related Signatures as Predictors and Correlates of Depression. Neuropsychopharmacology. 2016 Sep;41(10):2502-11. doi: 10.1038/npp.2016.50. Epub 2016 Apr 12.
PubMed 27067128Carvalho 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 23200297Branchi I, Poggini S, Capuron L, Benedetti F, Poletti S, Tamouza R, Drexhage HA, Penninx BWJH, Pariante CM; European College of Neuropsychopharmacology (ECNP) ImmunoNeuroPsychiatry Thematic Working Group and Marion Leboyer. Brain-immune crosstalk in the treatment of major depressive disorder. Eur Neuropsychopharmacol. 2021 Apr;45:89-107. doi: 10.1016/j.euroneuro.2020.11.016. Epub 2020 Dec 29.
PubMed 33386229Dinan TG. Inflammatory markers in depression. Curr Opin Psychiatry. 2009 Jan;22(1):32-6. doi: 10.1097/YCO.0b013e328315a561.
PubMed 19122532Otte C, Gold SM, Penninx BW, Pariante CM, Etkin A, Fava M, Mohr DC, Schatzberg AF. Major depressive disorder. Nat Rev Dis Primers. 2016 Sep 15;2:16065. doi: 10.1038/nrdp.2016.65.
PubMed 27629598Kohler O, Benros ME, Nordentoft M, Farkouh ME, Iyengar RL, Mors O, Krogh J. Effect of anti-inflammatory treatment on depression, depressive symptoms, and adverse effects: a systematic review and meta-analysis of randomized clinical trials. JAMA Psychiatry. 2014 Dec 1;71(12):1381-91. doi: 10.1001/jamapsychiatry.2014.1611.
PubMed 25322082Muller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Muller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Moller HJ, Arolt V, Riedel M. The cyclooxygenase-2 inhibitor celecoxib has therapeutic effects in major depression: results of a double-blind, randomized, placebo controlled, add-on pilot study to reboxetine. Mol Psychiatry. 2006 Jul;11(7):680-4. doi: 10.1038/sj.mp.4001805. Epub 2006 Feb 21.
PubMed 16491133Wittenberg GM, Stylianou A, Zhang Y, Sun Y, Gupta A, Jagannatha PS, Wang D, Hsu B, Curran ME, Khan S; MRC ImmunoPsychiatry Consortium; Chen G, Bullmore ET, Drevets WC. Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders. Mol Psychiatry. 2020 Jun;25(6):1275-1285. doi: 10.1038/s41380-019-0471-8. Epub 2019 Aug 19.
PubMed 31427751Warner-Schmidt JL, Vanover KE, Chen EY, Marshall JJ, Greengard P. Antidepressant effects of selective serotonin reuptake inhibitors (SSRIs) are attenuated by antiinflammatory drugs in mice and humans. Proc Natl Acad Sci U S A. 2011 May 31;108(22):9262-7. doi: 10.1073/pnas.1104836108. Epub 2011 Apr 25.
PubMed 21518864Dallaspezia S, Benedetti F. Chronobiological therapy for mood disorders. Expert Rev Neurother. 2011 Jul;11(7):961-70. doi: 10.1586/ern.11.61.
PubMed 21721914
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjusting Immune Activation to Reinstate Neural Plasticity and Promote the Beneficial Effect of Non-pharmacological Interventions
- ClinicalTrials.gov ID
- NCT06306248
- Acronym / sponsor ID
- PNRR-MAD-2022-12375716
- Conditions
- Mood Disorders, Major Depressive Disorder, Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 9 May 2025 (estimated)
- First posted
- 12 Mar 2024 (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.
Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD patients | – | Other: Total sleep deprivation60 patients with a depressive episode in course of major depression (MDD) and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT). Each subject will participate in the study for 6 months, will undergo MRI and clinical evaluation that will take overall about 2 hours at baseline (V0), after one week of chronobiological treatment and at 6 month follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with major depressive disorder
Key inclusion criteria (5 listed)
- A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD with:
- Signed informed consent, able to understand, speak and write the national language
Key exclusion criteria (17 listed)
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa;
- Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants
- Active infection requiring antibiotics therapy;
- Immunosuppressed patient or other chronic diseases
- Signs of active infection requiring treatment
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 |
|---|---|---|
| Total sleep deprivationnon pharmacologic treatment for depression | Other | MDD patients |
Primary outcome
BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients.
Time frame: at baseline, 1 week follow-up, 6 months follow up
Response to total sleep deprivation will be measured (50% reduction in hamilton depression rating scale (HDRS), min score 0 max 52; higher scores higher severity of depression) in patients with C reactive protein levels <3 and >=3 mg/L.
1 secondary outcome
Neurobiological markers of prediction and progression of antidepressant treatment
Time frame: from baseline to 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 16390886Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006 Jan;163(1):28-40. doi: 10.1176/appi.ajp.163.1.28.
- Background: PubMed 34539454Benedetti F, Dallaspezia S, Melloni EMT, Lorenzi C, Zanardi R, Barbini B, Colombo C. Effective Antidepressant Chronotherapeutics (Sleep Deprivation and Light Therapy) Normalize the IL-1beta:IL-1ra Ratio in Bipolar Depression. Front Physiol. 2021 Sep 1;12:740686. doi: 10.3389/fphys.2021.740686. eCollection 2021.
- Background: PubMed 26711676Miller AH, Raison CL. The role of inflammation in depression: from evolutionary imperative to modern treatment target. Nat Rev Immunol. 2016 Jan;16(1):22-34. doi: 10.1038/nri.2015.5.
- Background: PubMed 27788673Leboyer M, Berk M, Yolken RH, Tamouza R, Kupfer D, Groc L. Immuno-psychiatry: an agenda for clinical practice and innovative research. BMC Med. 2016 Oct 28;14(1):173. doi: 10.1186/s12916-016-0712-5.
- Background: PubMed 19423079Harrison NA, Brydon L, Walker C, Gray MA, Steptoe A, Critchley HD. Inflammation causes mood changes through alterations in subgenual cingulate activity and mesolimbic connectivity. Biol Psychiatry. 2009 Sep 1;66(5):407-14. doi: 10.1016/j.biopsych.2009.03.015. Epub 2009 May 7.
- Background: PubMed 27067128Hepgul N, Cattaneo A, Agarwal K, Baraldi S, Borsini A, Bufalino C, Forton DM, Mondelli V, Nikkheslat N, Lopizzo N, Riva MA, Russell A, Hotopf M, Pariante CM. Transcriptomics in Interferon-alpha-Treated Patients Identifies Inflammation-, Neuroplasticity- and Oxidative Stress-Related Signatures as Predictors and Correlates of Depression. Neuropsychopharmacology. 2016 Sep;41(10):2502-11. doi: 10.1038/npp.2016.50. Epub 2016 Apr 12.
- 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.
- Background: PubMed 33386229Branchi I, Poggini S, Capuron L, Benedetti F, Poletti S, Tamouza R, Drexhage HA, Penninx BWJH, Pariante CM; European College of Neuropsychopharmacology (ECNP) ImmunoNeuroPsychiatry Thematic Working Group and Marion Leboyer. Brain-immune crosstalk in the treatment of major depressive disorder. Eur Neuropsychopharmacol. 2021 Apr;45:89-107. doi: 10.1016/j.euroneuro.2020.11.016. Epub 2020 Dec 29.
- Background: PubMed 19122532Dinan TG. Inflammatory markers in depression. Curr Opin Psychiatry. 2009 Jan;22(1):32-6. doi: 10.1097/YCO.0b013e328315a561.
- Background: PubMed 27629598Otte C, Gold SM, Penninx BW, Pariante CM, Etkin A, Fava M, Mohr DC, Schatzberg AF. Major depressive disorder. Nat Rev Dis Primers. 2016 Sep 15;2:16065. doi: 10.1038/nrdp.2016.65.
- Background: PubMed 25322082Kohler O, Benros ME, Nordentoft M, Farkouh ME, Iyengar RL, Mors O, Krogh J. Effect of anti-inflammatory treatment on depression, depressive symptoms, and adverse effects: a systematic review and meta-analysis of randomized clinical trials. JAMA Psychiatry. 2014 Dec 1;71(12):1381-91. doi: 10.1001/jamapsychiatry.2014.1611.
- Background: PubMed 16491133Muller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Muller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Moller HJ, Arolt V, Riedel M. The cyclooxygenase-2 inhibitor celecoxib has therapeutic effects in major depression: results of a double-blind, randomized, placebo controlled, add-on pilot study to reboxetine. Mol Psychiatry. 2006 Jul;11(7):680-4. doi: 10.1038/sj.mp.4001805. Epub 2006 Feb 21.
- 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.
Sara Poletti, PhD principal investigator
IRCCS Ospedale San Raffaele
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 Mood Disorders and Major Depressive Disorder, run by IRCCS San Raffaele at 1 site in Italy.
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 5 inclusion and 17 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 12 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Poletti, phd (+390226433156, poletti.sara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients. (time frame: at baseline, 1 week follow-up, 6 months follow up). 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 NCT06306248, which also lists 16 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 12 Mar 2024.