NCT03217357

Brief Summary

An exacerbated response to stress mediated by activation of the Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected siblings of patients) displayed an intermediate hyperreactivity to stress as compared with patients and healthy controls. Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol can modulate decision making processes and modulate biological reactivity to stress by decreasing salivary cortisol concentration in acute stress condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2019

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

July 5, 2017

Last Update Submit

February 22, 2024

Conditions

Schizophrenia

Keywords

tDCS, non invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

  • Cortisol

    Salivary cortisol will be analyzed, using Salivette tubes

    One year

Secondary Outcomes (2)

  • Decision-making capacities

    6 mois

  • electroencephalography

    6 mois

Study Arms (2)

Transcranial stimulation in direct current(tDCS)active

ACTIVE COMPARATOR

30 minutes of active Transcranial stimulation in direct current

Device: Transcranial stimulation in direct current

Transcranial stimulation in direct current(tDCS) placebo

PLACEBO COMPARATOR

30 minutes of placebo stimulation

Device: Transcranial stimulation in direct current

Interventions

Transcranial stimulation in direct currentDEVICE

tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC) active or placebo

Transcranial stimulation in direct current(tDCS) placeboTranscranial stimulation in direct current(tDCS)active

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject to genetic risk of schizophrenia, related first-degree schizophrenic patient
  • Man and woman
  • Age between 18 and 30 years old

You may not qualify if:

  • Contraindications to the practice of the tDCS, for safety measure, we will use the same contraindications as the practice of the Magnetic resonance imaging
  • Psychiatric disorder on axis I of DSM 5
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • D AMATO THIERRY, MD - PhD

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The subject will be blind of the treatment he receives (active or placebo). \- The experimenter will also be blinded from stimulation (active or placebo) Each subject will be assigned a randomization code, corresponding to the code to enter the tDCS device. This system allows the person who administers tDCS and the subject receiving the stimulation to be blind .
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: In a randomized controlled double blind study, 30 subjects, first-degree relatives of schizophrenic patients, were randomly assigned to 2 groups. A group of 15 participants will receive 30 minutes of active tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC); A group of 15 participants will receive 30 minutes of placebo stimulation. During this stimulation session, all participants will undergo a standardized stress test combining psychosocial stress and physical stress
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 14, 2017

Study Start

May 2, 2019

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)