Schizophrenia Treatment With Photoneuromodulation

Phase 2

• Conditions: Schizophrenia
• Interventions: Device: Photoneuromodulation

• Registration Number: NCT05339347
• Lead Sponsor: University of Sao Paulo

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21
• Primary Completion: 2022-06-01
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Comparator: Active Photoneuromodulation	Photoneuromodulation	Active stimulation with light fields as described in the intervention
Sham Comparator: Sham Photoneuromodulation	Photoneuromodulation	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.

Primary Outcome Measures

Name	Time	Method
Changes in Subcale of PANSS	Weeks 0, 2 and 4	Continuos measure (score changes)

Secondary Outcome Measures

Name	Time	Method
Changes in PANSS	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]	Continuous measure (score changes).
Changes in Brief Negative Symptom Scale (BNSS)	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]	Continuous measure (score changes).
Changes in Calgary	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]	Continuous measure (score changes).
Changes in WHOQOL	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]	Continuous measure (score changes).
Changes in SOFAS	Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]	Continuous measure (score changes).
Changes in SANS	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]	Continuous measure (score changes).
Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)	Time Frame: Weeks 0, 2, 4]	Continuous measure (score changes).

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil