Chronic SchizophreniatDCSNCT06349369
Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia
A study testing transcranial direct current stimulation in people with Chronic Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Schizophrenia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 8 Apr 2024to 9 Apr 2026
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients clinically diagnosed with schizophrenia (F20 according to ICD-11) for a period more than 2 years receiving antipsychotics.
- 2. Moderate to severe symptoms (PANSS score >75 and/or CGI-SGH score >4) 3. Patients of both sex 18-60 years 4. Right-handed. 5. Legally authorized representative (LAR) giving voluntary written consent for participation in the study.
Who cannot join
- 1. Patients with chance of pregnancy. 2. Any psychiatric emergency (e.g. suicidal risk, catatonia, prolonged nutritional deprivation) or others (e.g.: aggression or excitement) 3. Co-morbid neurological disease: i) History of migraine. ii) History of seizure/epilepsy. iii) History of head trauma or organic disease.
- 4. Any contraindication to tDCS procedure: i) Injury or local lesion in the scalp/head ii) Metallic implants in the head iii) Implanted brain medical devices 5. Left-handed.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
AIIMS Bhubaneswar
Bhubaneswar, Odisha, 751019
Ashutosh Biswas
About this study
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Inflammatory Biomarkers in Chronic Schizophrenia: A Randomised Double-Blind Controlled Trial.
The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes.
- Conditions
- Chronic Schizophrenia
- Being tested
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
tDCS is a non-invasive neuromodulation technique that has gained attention for its potential to influence neural activity and address cognitive and functional deficits in individuals with schizophrenia. It involves applying a weak direct electrical current to the scalp, which can increase or decrease the excitability of underlying brain regions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | the cathode will be located over a point midway between T3 and P3 (left temporo-parietal junction, assumed to correspond to a region including BA 22, 39, 40, 41, and 42, depending on the patient) and the anode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex, assumed to correspond to a region including Brodmann's areas [BA] 8, 9, 10, and 46, depending on the patient).The transcranial brain stimulation will be given 2 sessions per day for 10 days, in which 20 minutes of stimulation with an inter-session interval of 3 hours. Receives: Device: transcranial direct current stimulation |
| Sham control group | Sham comparator | To Maximize the stimulatory effects 1mA current will be applied for the first 30 seconds, to provide the initial sensation of real stimulation and then the current will be stopped, thus minimizing the stimulatory effects. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the IL-6 levels
Measured: 10 days
Secondary outcomes (6)
Change in the TNF alpha levels.
Measured: 10 days
Change in the Positive and Negative syndrome Scale
score 1- absent symptoms Score 7- extreme symptoms
Measured: 5 days and 10 days
Change in the Auditory hallucination rating scale
score 0- No Auditory hallucination Score 9- Severe Auditory hallucination
Measured: 5 days and 10 days
Change in the Clinical global impression- Schizophrenia scale
score 0- not assessed score 7- extremely ill patients
Measured: 5 days and 10 days
Change in the Global Assessment of Functioning scale
score 0- inadequate information score 100- No symptoms
Measured: 5 days and 10 days
To compare the adverse events reported in both control and intervention groups.
Measured: 5 days and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start8 Apr 2024
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Debadatta Mohapatra, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349369
- Sponsor's protocol ID
- PG Thesis/2023-24/105
- Acronym
- tDCS
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.
PubMed 26652115Vaseghi B, Zoghi M, Jaberzadeh S. A meta-analysis of site-specific effects of cathodal transcranial direct current stimulation on sensory perception and pain. PLoS One. 2015 May 15;10(5):e0123873. doi: 10.1371/journal.pone.0123873. eCollection 2015.
PubMed 25978673Xu H, Zhou Y, Wang J, Liang Z, Wang Y, Wu W, Liu Y, Liu X, Zhang X, Huo L. Effect of HD-tDCS on white matter integrity and associated cognitive function in chronic schizophrenia: A double-blind, sham-controlled randomized trial. Psychiatry Res. 2023 Jun;324:115183. doi: 10.1016/j.psychres.2023.115183. Epub 2023 Mar 27.
PubMed 37028258Hafner H, an der Heiden W. Epidemiology of schizophrenia. Can J Psychiatry. 1997 Mar;42(2):139-51. doi: 10.1177/070674379704200204.
PubMed 9067063Schennach R, Riedel M, Obermeier M, Spellmann I, Musil R, Jager M, Schmauss M, Laux G, Pfeiffer H, Naber D, Schmidt LG, Gaebel W, Klosterkotter J, Heuser I, Maier W, Lemke MR, Ruther E, Klingberg S, Gastpar M, Moller HJ. What are residual symptoms in schizophrenia spectrum disorder? Clinical description and 1-year persistence within a naturalistic trial. Eur Arch Psychiatry Clin Neurosci. 2015 Mar;265(2):107-16. doi: 10.1007/s00406-014-0528-2. Epub 2014 Sep 27.
PubMed 25261210Palm U, Keeser D, Hasan A, Kupka MJ, Blautzik J, Sarubin N, Kaymakanova F, Unger I, Falkai P, Meindl T, Ertl-Wagner B, Padberg F. Prefrontal Transcranial Direct Current Stimulation for Treatment of Schizophrenia With Predominant Negative Symptoms: A Double-Blind, Sham-Controlled Proof-of-Concept Study. Schizophr Bull. 2016 Sep;42(5):1253-61. doi: 10.1093/schbul/sbw041. Epub 2016 Apr 20.
PubMed 27098066Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28.
PubMed 28655284Muller N, Weidinger E, Leitner B, Schwarz MJ. The role of inflammation in schizophrenia. Front Neurosci. 2015 Oct 21;9:372. doi: 10.3389/fnins.2015.00372. eCollection 2015.
PubMed 26539073Huarcaya-Victoria J, Villarreal-Rao B, Luna M, Rojas-Mendoza W, Alarcon-Ruiz CA, Villarreal-Zegarra D, Vilela-Estrada AL, Ramirez S. Factors Associated with Mental Health Outcomes in Hospital Workers during the COVID-19 Pandemic: A Mixed-Methods Study. Int J Environ Res Public Health. 2022 Apr 28;19(9):5346. doi: 10.3390/ijerph19095346.
PubMed 35564741Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.
PubMed 29213226Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
PubMed 22581236Valiengo LDCL, Goerigk S, Gordon PC, Padberg F, Serpa MH, Koebe S, Santos LAD, Lovera RAM, Carvalho JB, van de Bilt M, Lacerda ALT, Elkis H, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):121-129. doi: 10.1001/jamapsychiatry.2019.3199.
PubMed 31617873Goerigk S, Cretaz E, Sampaio-Junior B, Vieira ELM, Gattaz W, Klein I, Lafer B, Teixeira AL, Carvalho AF, Lotufo PA, Bensenor IM, Buhner M, Padberg F, Brunoni AR. Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110119. doi: 10.1016/j.pnpbp.2020.110119. Epub 2020 Oct 4.
PubMed 33022345Agarwal SM, Shivakumar V, Bose A, Subramaniam A, Nawani H, Chhabra H, Kalmady SV, Narayanaswamy JC, Venkatasubramanian G. Transcranial direct current stimulation in schizophrenia. Clin Psychopharmacol Neurosci. 2013 Dec;11(3):118-25. doi: 10.9758/cpn.2013.11.3.118. Epub 2013 Dec 24.
PubMed 24465247
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation (tDCS) on Inflammatory Biomarkers in Chronic Schizophrenia: A Randomised Double-Blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT06349369
- Acronym / sponsor ID
- tDCS / PG Thesis/2023-24/105
- Conditions
- Chronic Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Apr 2026 (estimated)
- First posted
- 5 Apr 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.
The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: transcranial direct current stimulationthe cathode will be located over a point midway between T3 and P3 (left temporo-parietal junction, assumed to correspond to a region including BA 22, 39, 40, 41, and 42, depending on the patient) and the anode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex, assumed to correspond to a region including Brodmann's areas [BA] 8, 9, 10, and 46, depending on the patient).The transcranial brain stimulation will be given 2 sessions per day for 10 days, in which 20 minutes of stimulation with an inter-session interval of 3 hours. |
| Sham control group | Sham comparator | Device: transcranial direct current stimulationTo Maximize the stimulatory effects 1mA current will be applied for the first 30 seconds, to provide the initial sensation of real stimulation and then the current will be stopped, thus minimizing the stimulatory effects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Patients clinically diagnosed with schizophrenia (F20 according to ICD-11) for a period more than 2 years receiving antipsychotics.
- 2. Moderate to severe symptoms (PANSS score >75 and/or CGI-SGH score >4) 3. Patients of both sex 18-60 years 4. Right-handed. 5. Legally authorized representative (LAR) giving voluntary written consent for participation in the study.
Key exclusion criteria (2 listed)
- 1. Patients with chance of pregnancy. 2. Any psychiatric emergency (e.g. suicidal risk, catatonia, prolonged nutritional deprivation) or others (e.g.: aggression or excitement) 3. Co-morbid neurological disease: i) History of migraine. ii) History of seizure/epilepsy. iii) History of head trauma or organic disease.
- 4. Any contraindication to tDCS procedure: i) Injury or local lesion in the scalp/head ii) Metallic implants in the head iii) Implanted brain medical devices 5. Left-handed.
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 |
|---|---|---|
| transcranial direct current stimulationtDCS is a non-invasive neuromodulation technique that has gained attention for its potential to influence neural activity and address cognitive and functional deficits in individuals with schizophrenia. It involves applying a weak direct electrical current to the scalp, which can increase or decrease the excitability of underlying brain regions. | Device | Sham control group, Treatment group |
Primary outcome
Change in the IL-6 levels
Time frame: 10 days
6 secondary outcomes
Change in the TNF alpha levels.
Time frame: 10 days
Change in the Positive and Negative syndrome Scale
Time frame: 5 days and 10 days
Change in the Auditory hallucination rating scale
Time frame: 5 days and 10 days
Change in the Clinical global impression- Schizophrenia scale
Time frame: 5 days and 10 days
Change in the Global Assessment of Functioning scale
Time frame: 5 days and 10 days
To compare the adverse events reported in both control and intervention groups.
Time frame: 5 days and 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Results publication: PubMed 26652115Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.
- Results publication: PubMed 25978673Vaseghi B, Zoghi M, Jaberzadeh S. A meta-analysis of site-specific effects of cathodal transcranial direct current stimulation on sensory perception and pain. PLoS One. 2015 May 15;10(5):e0123873. doi: 10.1371/journal.pone.0123873. eCollection 2015.
- Results publication: PubMed 37028258Xu H, Zhou Y, Wang J, Liang Z, Wang Y, Wu W, Liu Y, Liu X, Zhang X, Huo L. Effect of HD-tDCS on white matter integrity and associated cognitive function in chronic schizophrenia: A double-blind, sham-controlled randomized trial. Psychiatry Res. 2023 Jun;324:115183. doi: 10.1016/j.psychres.2023.115183. Epub 2023 Mar 27.
- Results publication: PubMed 9067063Hafner H, an der Heiden W. Epidemiology of schizophrenia. Can J Psychiatry. 1997 Mar;42(2):139-51. doi: 10.1177/070674379704200204.
- Results publication: PubMed 25261210Schennach R, Riedel M, Obermeier M, Spellmann I, Musil R, Jager M, Schmauss M, Laux G, Pfeiffer H, Naber D, Schmidt LG, Gaebel W, Klosterkotter J, Heuser I, Maier W, Lemke MR, Ruther E, Klingberg S, Gastpar M, Moller HJ. What are residual symptoms in schizophrenia spectrum disorder? Clinical description and 1-year persistence within a naturalistic trial. Eur Arch Psychiatry Clin Neurosci. 2015 Mar;265(2):107-16. doi: 10.1007/s00406-014-0528-2. Epub 2014 Sep 27.
- Results publication: PubMed 27098066Palm U, Keeser D, Hasan A, Kupka MJ, Blautzik J, Sarubin N, Kaymakanova F, Unger I, Falkai P, Meindl T, Ertl-Wagner B, Padberg F. Prefrontal Transcranial Direct Current Stimulation for Treatment of Schizophrenia With Predominant Negative Symptoms: A Double-Blind, Sham-Controlled Proof-of-Concept Study. Schizophr Bull. 2016 Sep;42(5):1253-61. doi: 10.1093/schbul/sbw041. Epub 2016 Apr 20.
- Results publication: PubMed 28655284Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28.
- Results publication: PubMed 26539073Muller N, Weidinger E, Leitner B, Schwarz MJ. The role of inflammation in schizophrenia. Front Neurosci. 2015 Oct 21;9:372. doi: 10.3389/fnins.2015.00372. eCollection 2015.
- Results publication: PubMed 35564741Huarcaya-Victoria J, Villarreal-Rao B, Luna M, Rojas-Mendoza W, Alarcon-Ruiz CA, Villarreal-Zegarra D, Vilela-Estrada AL, Ramirez S. Factors Associated with Mental Health Outcomes in Hospital Workers during the COVID-19 Pandemic: A Mixed-Methods Study. Int J Environ Res Public Health. 2022 Apr 28;19(9):5346. doi: 10.3390/ijerph19095346.
- Results publication: PubMed 29213226Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.
- Results publication: PubMed 22581236Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
- Results publication: PubMed 31617873Valiengo LDCL, Goerigk S, Gordon PC, Padberg F, Serpa MH, Koebe S, Santos LAD, Lovera RAM, Carvalho JB, van de Bilt M, Lacerda ALT, Elkis H, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):121-129. doi: 10.1001/jamapsychiatry.2019.3199.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Chronic Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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 2 inclusion and 2 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 25 Apr 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 India. 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.
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 Dr. Debadatta Mohapatra, MD (9437658251, psych_debadatta@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the IL-6 levels (time frame: 10 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 NCT06349369, which also lists 14 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 25 Apr 2024.