Schizophrenia Treatment With Photoneuromodulation

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339347
• Other study ID #: 4.545.487
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2022
• Source: University of Sao Paulo
• Contact: Leandro Valinego, PhD
• Phone: +55 11 2661-8159
• Email: pesquisa.esquizofrenia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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,

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Photoneuromodulation
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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Subcale of PANSS	Continuos measure (score changes)	Weeks 0, 2 and 4
Secondary	Changes in PANSS	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Secondary	Changes in WHOQOL	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Secondary	Changes in Brief Negative Symptom Scale (BNSS)	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Secondary	Changes in Calgary	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Secondary	Changes in SOFAS	Continuous measure (score changes).	Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
Secondary	Changes in SANS	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Secondary	Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)	Continuous measure (score changes).	Time Frame: Weeks 0, 2, 4]