Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

NCT ID: NCT02451371

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia Refractory auditory hallucination tDCS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tDCS

Patients with schizophrenia to receive tDCS treatment

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

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

Interventions

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tDCS

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

Intervention Type DEVICE

Other Intervention Names

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YDT-201N

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Soo Kwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1501-022-638

Identifier Type: -

Identifier Source: org_study_id