Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

NCT ID: NCT02661347

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-01

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active comparator: tDCS & Risperidone

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.

Group Type: ACTIVE_COMPARATOR

Risperidone

Intervention Type: DRUG

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.

tDCS

Intervention Type: DEVICE

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.

Sham comparator: tDCS & Risperidone

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.

Group Type: SHAM_COMPARATOR

Risperidone

Intervention Type: DRUG

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.

tDCS

Intervention Type: DEVICE

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.

Interventions

Risperidone

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: DRUG

tDCS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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.

3. 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

4. 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,

5. age 15 to 40.

6. competent and willing to sign informed consent.

7. for women, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion Criteria

1. serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain.

2. any medical condition which requires treatment with a medication with psychotropic effects.

3. significant risk of suicidal or homicidal behavior;

4. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.

5. medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure).

6. lack of response to a prior adequate trial of risperidone.

7. requires treatment with an antidepressant or mood stabilizing medication.

8. presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system.

9. 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.).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Deepak Sarpal

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepak Sarpal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Zucker-Hillside Hospital

Glen Oaks, New York, United States

Countries

United States

Other Identifiers

IRB# 15-0701

Identifier Type: -

Identifier Source: org_study_id