NCT02451371

Brief Summary

The purpose of this study is to exploratively evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience persistent auditory verbal hallucinations after adequate antipsychotics therapy for over three months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1 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

April 27, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

April 27, 2015

Last Update Submit

December 28, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaRefractory auditory hallucinationtDCS

Outcome Measures

Primary Outcomes (1)

  • Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score

    Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales

    approximately 2 weeks

Secondary Outcomes (19)

  • Electroencephalography - resting

    approximately 2 weeks

  • Electroencephalography - P300 peak

    approximately 2 weeks

  • Electroencephalography - P300 source

    approximately 2 weeks

  • Electroencephalography - P50

    approximately 2 weeks

  • Electroencephalography - ERN (error-related negativity) peak

    approximately 2 weeks

  • +14 more secondary outcomes

Study Arms (1)

tDCS

EXPERIMENTAL

Patients with schizophrenia to receive tDCS treatment

Device: tDCS

Interventions

tDCSDEVICE

2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions

Also known as: YDT-201N
tDCS

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, Text Revision (DSM-IV-TR)
  • Presence of auditory hallucination after three months' trial of antipsychotics of adequate dose
  • The Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score is at least 8

You may not qualify if:

  • Significant brain pathology including head trauma, seizure, meningitis
  • Intellectual disability (IQ \< 70)
  • Severe personality disorder
  • Substance use disorder (except nicotine)
  • Severe medical illness
  • Disability in the sensory organs
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

SchizophreniaHallucinations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jun Soo Kwon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 22, 2015

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 30, 2016

Record last verified: 2016-08

Locations

KR(1)