Schizophrenia Treatment With Photoneuromodulation

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Device: Photoneuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05339347

4.545.487

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Active Comparator: Active Photoneuromodulation

Active Comparator group

Description:

Active stimulation with light fields as described in the intervention

Treatment:

Device: Photoneuromodulation

Sham Comparator: Sham Photoneuromodulation

Sham Comparator group

Description:

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.

Treatment:

Device: Photoneuromodulation