SchizophreniaPhase 2NCT05339347
Schizophrenia Treatment With Photoneuromodulation
A Phase 2 study testing Photoneuromodulation in people with Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Photoneuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2021to 11 Mar 2022
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18 and 55 years
- Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID (Structured Clinical Interview for DSMIV), which will be applied by a psychiatrist, will be included.
- Minimum score of 20 points in the sum of negative PANSS
- Stable antipsychotic medications
- There is a need for at least one trial with at least one antipsychotic in adequate dose and time to enter the study.
Who cannot join
- Unstable or uncontrolled clinical diseases,
- Psychiatric comorbidities,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.
Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. In this group of 30 refractory volunteers, magnetic resonance spectroscopy will be performed before and after photoneuromodulation in a cross-over design.
Objectives: Effectiveness of photoneuromodulation in patients with schizophrenia. . Analysis of glutamate, Gaba and lactate in spectroscopy before and after stimulation (secondary) Sample: 30 volunteers with negative symptoms of schizophrenia refractory to treatment.
Method: clinical trial, cross-over randomized, double-blind, sham-controlled. PANSS negative symptoms subscale evaluation before and after the 10 photoneuromodulation sessions. Participants who are in the active group after the 10 photoneuromodulation sessions will go to the sham group and vice versa. They will perform magnetic resonance spectroscopy before the beginning, after the 10 sessions and again after the inversion of the groups (3 resonances per volunteer). The study will be a cross-over: half of participants will start at sham group and the other half at active group and invert groups after 10th day of stimulation.
- Conditions
- Schizophrenia
- Being tested
- Photoneuromodulation
- Keywords
- Schizophrenia, Photoneuromodulation, Neuromodulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotoneuromodulationDevice
Treatments were administered daily for a period of 2 weeks (10 sessions) with a Light-Aid (Bright Photomedicine, SP, Brazil), continuous wave, 300 LED wavelength 850 nm) or with a placebo probe of the same appearance and display. The irradiation parameters created will be based on the disease, pain intensity and skin phototype. Each session has from 10 to 15 min, depending on skin phototype
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Active Photoneuromodulation | Active comparator | Active stimulation with light fields as described in the intervention Receives: Device: Photoneuromodulation |
| Sham Comparator: Sham Photoneuromodulation | Sham comparator | The blinding will be done with sham light, which consists of fields that do not reproduce light, but which have the same size and thickness as the true one. Receives: Device: Photoneuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Subcale of PANSS
Continuos measure (score changes)
Measured: Weeks 0, 2 and 4
Secondary outcomes (7)
Changes in PANSS
Continuous measure (score changes).
Measured: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in WHOQOL
Continuous measure (score changes).
Measured: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in Brief Negative Symptom Scale (BNSS)
Continuous measure (score changes).
Measured: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in Calgary
Continuous measure (score changes).
Measured: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in SOFAS
Continuous measure (score changes).
Measured: Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
Changes in SANS
Continuous measure (score changes).
Measured: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)
Continuous measure (score changes).
Measured: Time Frame: Weeks 0, 2, 4]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Aug 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For the sham, the tip has LED light similar to the real one, but without generating the light field. The treatments will be administered in two sessions (active/sham) with a Light-Aid (Bright Photomedicine, SP, Brazil), continuous wave, 300 LEDs, wavelength of 850 nm). The irradiation parameters created will be based on the skin phototype according to the Fitzpatrick Scale. The tip will be positioned in the prefrontal cortex (corresponding to F3 and F4 according to the 10-20 EEG system). This arrangement is commonly known as 'Bifrontal'. In each application, power densities between 45-50 mW/cm², frequency of 10 Hz, and total time of 10 to 15 minutes per session will be used. The tip used has a size equivalent to 70cm² each side.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandro Valiengo, University of Sao Paulo
- Investigators
- Leandro Valiengo, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339347
- Sponsor's protocol ID
- 4.545.487
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.
- ClinicalTrials.gov ID
- NCT05339347
- Acronym / sponsor ID
- 4.545.487
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Photoneuromodulation, Neuromodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 21 Apr 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.
Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. In this group of 30 refractory volunteers, magnetic resonance spectroscopy will be performed before and after photoneuromodulation in a cross-over design.
Objectives: Effectiveness of photoneuromodulation in patients with schizophrenia. . Analysis of glutamate, Gaba and lactate in spectroscopy before and after stimulation (secondary) Sample: 30 volunteers with negative symptoms of schizophrenia refractory to treatment.
Method: clinical trial, cross-over randomized, double-blind, sham-controlled. PANSS negative symptoms subscale evaluation before and after the 10 photoneuromodulation sessions. Participants who are in the active group after the 10 photoneuromodulation sessions will go to the sham group and vice versa. They will perform magnetic resonance spectroscopy before the beginning, after the 10 sessions and again after the inversion of the groups (3 resonances per volunteer). The study will be a cross-over: half of participants will start at sham group and the other half at active group and invert groups after 10th day of stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For the sham, the tip has LED light similar to the real one, but without generating the light field. The treatments will be administered in two sessions (active/sham) with a Light-Aid (Bright Photomedicine, SP, Brazil), continuous wave, 300 LEDs, wavelength of 850 nm). The irradiation parameters created will be based on the skin phototype according to the Fitzpatrick Scale. The tip will be positioned in the prefrontal cortex (corresponding to F3 and F4 according to the 10-20 EEG system). This arrangement is commonly known as 'Bifrontal'. In each application, power densities between 45-50 mW/cm², frequency of 10 Hz, and total time of 10 to 15 minutes per session will be used. The tip used has a size equivalent to 70cm² each side.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Active Photoneuromodulation | Active comparator | Device: PhotoneuromodulationActive stimulation with light fields as described in the intervention |
| Sham Comparator: Sham Photoneuromodulation | Sham comparator | Device: PhotoneuromodulationThe blinding will be done with sham light, which consists of fields that do not reproduce light, but which have the same size and thickness as the true one. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients between 18 and 55 years
- Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID (Structured Clinical Interview for DSMIV), which will be applied by a psychiatrist, will be included.
- Minimum score of 20 points in the sum of negative PANSS
- Stable antipsychotic medications
- There is a need for at least one trial with at least one antipsychotic in adequate dose and time to enter the study.
Key exclusion criteria (2 listed)
- Unstable or uncontrolled clinical diseases,
- Psychiatric comorbidities,
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 |
|---|---|---|
| PhotoneuromodulationTreatments were administered daily for a period of 2 weeks (10 sessions) with a Light-Aid (Bright Photomedicine, SP, Brazil), continuous wave, 300 LED wavelength 850 nm) or with a placebo probe of the same appearance and display. The irradiation parameters created will be based on the disease, pain intensity and skin phototype. Each session has from 10 to 15 min, depending on skin phototype | Device | Active Comparator: Active Photoneuromodulation, Sham Comparator: Sham Photoneuromodulation |
Primary outcome
Changes in Subcale of PANSS
Time frame: Weeks 0, 2 and 4
Continuos measure (score changes)
7 secondary outcomes
Changes in PANSS
Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in WHOQOL
Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in Brief Negative Symptom Scale (BNSS)
Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in Calgary
Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in SOFAS
Time frame: Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
Changes in SANS
Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)
Time frame: Time Frame: Weeks 0, 2, 4]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- 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.
Leandro Valiengo, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photoneuromodulation in people with Schizophrenia, run by University of Sao Paulo 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 5 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: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Subcale of PANSS (time frame: Weeks 0, 2 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.