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Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

Primary Purpose

Schizophrenia, Schizophreniform, Schizoaffective Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Risperidone

tDCS

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring First Episode, Schizophreniform, Schizoaffective Disorder, Psychosis, Schizophrenia, tDCS, Risperidone, Anti-psychotic medication

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

current Diagnostic and Statistical Manual-IV (DSM-IV) -defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, psychosis NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1994).
does not meet DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder with psychotic features.
current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content
current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity or unusual thought content and is in the first episode of the illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 4 weeks or less,
age 15 to 40.
competent and willing to sign informed consent.
for women, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion Criteria:

serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain.
any medical condition which requires treatment with a medication with psychotropic effects.
significant risk of suicidal or homicidal behavior;
cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure).
lack of response to a prior adequate trial of risperidone.
requires treatment with an antidepressant or mood stabilizing medication.
presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system.
damaged skin at the site of stimulation (i.e. skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).

Sites / Locations

Zucker-Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active comparator: tDCS & Risperidone

Sham comparator: tDCS & Risperidone

Arm Description

In the active arm, active tDCS will be applied using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator at a current of 2 milliampere (mA) for 20 minutes, twice a day for five consecutive days, for a total of 10 sessions.

In the sham arm, active tDCS will be applied using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator at a current of 2mA for 1 minute, twice a day for five consecutive days, for a total of 10 sessions.

Outcomes

Primary Outcome Measures

Auditory hallucinations

A decrease in verbal auditory hallucinations based on the Auditory Hallucinations Ratings Scale (AHRS).

Secondary Outcome Measures

Full Information

NCT ID

NCT02661347

First Posted

January 20, 2016

Last Updated

March 9, 2018

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02661347

Brief Title

Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

Official Title

Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulty in recruiting patients who met the eligibility criteria.

Study Start Date

February 2016 (undefined)

Primary Completion Date

December 1, 2016 (Actual)

Study Completion Date

December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to test the efficacy of transcranial direct current stimulation (tDCS) for the treatment of auditory hallucinations in patients currently on risperidone treatment who are experiencing recent onset psychosis.

Detailed Description

This study looks to investigate whether patients with recent onset psychosis may benefit from tDCS treatment. The main hypothesis to be tested in this study is that treatment with risperidone supplemented with tDCS will yield a decrease in auditory hallucinations and negative symptoms; and improve working memory and attention. To test this hypothesis the investigators will enroll 30 patients with recent-onset psychosis into a 16-week long randomized double blind controlled study of risperidone treatment supplemented with tDCS versus risperidone plus sham tDCS. Patients who present for treatment of a first psychotic episode with a schizophrenia spectrum diagnosis and who are eligible to undergo or are already on treatment with risperidone, will be randomized to either tDCS or sham tDCS twice a day for five consecutive days. Neuropsychological testing, Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) will be conducted at baseline, week 1 (after completion of tDCS or sham tDCS intervention) and week 16. Clinical interviews to assess symptoms and medical assessments for side effects will be done at baseline, weekly for the first four weeks and then every two weeks until study completion. The primary outcome measure will be the Auditory Hallucinations Rating Scale (AHRS) score. Specific aims are: To determine the efficacy of tDCS for auditory hallucinations in patients with first episode schizophrenia. The investigators hypothesize that risperidone plus tDCS is associated with a faster and more robust decrease in auditory hallucinations compared to risperidone plus sham tDCS. To test the efficacy of tDCS in cognitive and negative symptoms in patients with first episode schizophrenia. The investigators hypothesize that tDCS improves working memory, attention/vigilance and decreases negative symptoms. To examine the neuronal basis of tDCS effects in ameliorating auditory hallucinations in schizophrenia by conducting event-related potential (ERP) and resting state EEG. The investigators hypothesize that the Delta N-100 amplitude is associated with improvement of auditory hallucinations after tDCS treatment. To determine the effects of tDCS on brain structure and function by conducting structural MRI, diffusion tensor imaging (DTI) and functional magnetic resonance imaging (fMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizophreniform, Schizoaffective Disorder, Psychosis Not Otherwise Specified (NOS)

Keywords

First Episode, Schizophreniform, Schizoaffective Disorder, Psychosis, Schizophrenia, tDCS, Risperidone, Anti-psychotic medication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active comparator: tDCS & Risperidone

Arm Type

Active Comparator

Arm Description

Arm Title

Sham comparator: tDCS & Risperidone

Arm Type

Sham Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Risperidone

Intervention Description

The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.

Intervention Type

Device

Intervention Name(s)

tDCS

Intervention Description

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which sub-threshold transcranial electric current (in the range of 0.4-2 mA) is applied via two conductive saline soaked electrodes placed on the scalp using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator.

Primary Outcome Measure Information:

Title

Auditory hallucinations

Description

A decrease in verbal auditory hallucinations based on the Auditory Hallucinations Ratings Scale (AHRS).

Time Frame

16 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: current Diagnostic and Statistical Manual-IV (DSM-IV) -defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, psychosis NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1994). does not meet DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder with psychotic features. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity or unusual thought content and is in the first episode of the illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 4 weeks or less, age 15 to 40. competent and willing to sign informed consent. for women, negative pregnancy test and agreement to use a medically accepted birth control method. Exclusion Criteria: serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain. any medical condition which requires treatment with a medication with psychotropic effects. significant risk of suicidal or homicidal behavior; cognitive or language limitations, or any other factor that would preclude subjects providing informed consent. medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure). lack of response to a prior adequate trial of risperidone. requires treatment with an antidepressant or mood stabilizing medication. presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system. damaged skin at the site of stimulation (i.e. skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deepak Sarpal, M.D.

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zucker-Hillside Hospital

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

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