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Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

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ClinicalTrials.gov Identifier: NCT02661347
Recruitment Status : Withdrawn (Difficulty in recruiting patients who met the eligibility criteria.)
First Posted : January 22, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Deepak Sarpal, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Schizoaffective Disorder Psychosis Not Otherwise Specified (NOS) Drug: Risperidone Device: tDCS Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia
Study Start Date : February 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.

Device: 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.

Sham Comparator: 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.
Drug: 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.

Device: 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.




Primary Outcome Measures :
  1. Auditory hallucinations [ Time Frame: 16 Weeks ]
    A decrease in verbal auditory hallucinations based on the Auditory Hallucinations Ratings Scale (AHRS).



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661347


Locations
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United States, New York
Zucker-Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Deepak Sarpal, M.D. Northwell Health

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Responsible Party: Deepak Sarpal, Psychiatrist, Northwell Health
ClinicalTrials.gov Identifier: NCT02661347     History of Changes
Other Study ID Numbers: IRB# 15-0701
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Deepak Sarpal, Northwell Health:
First Episode
Schizophreniform
Schizoaffective Disorder
Psychosis
Schizophrenia
tDCS
Risperidone
Anti-psychotic medication

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents