Schizophrenia Clinical Trial
Official title:
Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia
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.
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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