Status:
TERMINATED
Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Childhood Onset Psychotic Disorders
Schizophrenia
Eligibility:
All Genders
10+ years
Phase:
PHASE1
Brief Summary
This study will test whether transcranial direct current stimulation (TDCS) can be used safely in children with schizophrenia and if it can improve memory and attention span or auditory hallucinations...
Detailed Description
Background: The majority (about 75%) of patients with childhood onset schizophrenia still have impairing cognitive and psychotic symptoms after drug treatment optimization. Recent studies with transcr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- COS patients (age 10 and above) recruited and followed under the current protocol 03-M-0035, where subjects have been stable (in the judgment of the investigator) on their medications for 2 months with or without PRN medications but continue to experience either:
- Cognitive difficulties as evidenced by information from parents and teachers, clinical interview, and performance (below average based on published norms for each test) on neurocognitive tests (WMS-III Spatial Span (nonverbal) and WMS-III Letter-Number Sequencing (verbal) attention/vigilance (CPT-IP), and verbal learning (HVLT-R), all sub tests of the NIMH MATRICS battery).
- Significant auditory hallucinations as measured by SAPS (scores above 2) or BPRS (scores above 3).
- EXCLUSION CRITERIA:
- In addition to the exclusion criteria under protocol 03-M-0035, the following will be exclusionary:
- Broken or abnormal skin in the area of the electrodes.
- Presence of metal in the cranial cavity.
- Holes in the skull from trauma or surgery.
- Positive pregnancy test.
- Presence of other psychiatric illness (e.g. severe anxiety, OCD etc) unless the patient has been on stable medication for the prior 2 months
Exclusion
Key Trial Info
Start Date :
September 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00757497
Start Date
September 17 2008
End Date
August 18 2015
Last Update
December 12 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892