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Completed

NCT Number: NCT05339347

Schizophrenia Treatment With Photoneuromodulation

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Sao Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unstable or uncontrolled clinical diseases,
  • Psychiatric comorbidities,

Treatment and study plan

Photoneuromodulation

Device

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

Primary outcomes

  1. Changes in Subcale of PANSS

    Time frame: Weeks 0, 2 and 4

    Continuos measure (score changes)

Secondary outcomes

  1. Changes in PANSS

    Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

    Continuous measure (score changes).

  2. Changes in WHOQOL

    Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

    Continuous measure (score changes).

  3. Changes in Brief Negative Symptom Scale (BNSS)

    Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

    Continuous measure (score changes).

  4. Changes in Calgary

    Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

    Continuous measure (score changes).

  5. Changes in SOFAS

    Time frame: Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]

    Continuous measure (score changes).

  6. Changes in SANS

    Time frame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

    Continuous measure (score changes).

  7. Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)

    Time frame: Time Frame: Weeks 0, 2, 4]

    Continuous measure (score changes).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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