Status:
COMPLETED
TDCS for Auditory Hallucinations in Schizophrenia
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of the present research is to test a potential new treatment for auditory verbal hallucinations in schizophrenia that uses transcranial Direct Current Stimulation (tDCS), a neurostimulatio...
Detailed Description
90 patients with persistent auditory verbal hallucinations will be recruited to this study. Each individual will participate in behavioral assessments lasting up to 3 hours each and will then be rando...
Eligibility Criteria
Inclusion
- Age between 18-55
- Structured Clinical Interview for DSM Disorders (SCID) primary diagnosis of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-Version IV) schizophrenia or schizoaffective disorder
- Persistent auditory verbal hallucinations
- Right handed
- Stable antipsychotic medication for \> 4 weeks
- Normal hearing
- If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an interuterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception
- Willing/capacity to provide informed consent
Exclusion
- Substance dependence or abuse (excluding nicotine) in the past 90 days
- Current significant laboratory abnormality
- History of seizure, epilepsy in self or fist degree relatives, stroke, brain surgery, head injury with loss of consciousness \> 1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion, devices that may be affected by transcranial Direct Current Stimulation (tDCS) (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Frequent and persistent migraines
- History of adverse reaction to neurostimulation or open skin wounds that would preclude safe placement of tDCS electrodes
- Participation in study of investigational medication/device within 4 weeks
- Current use of medications known to lower seizure threshold (lithium, serotonergic or tricyclic antidepressants)
- If female, pregnant or breast feeding at the time of screening
- For MRI study only: Claustrophobia or metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined according to the guidelines set forth in the following reference book: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott-Raven press, NY 1998
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01898299
Start Date
May 1 2013
End Date
August 14 2018
Last Update
March 23 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
New York State Psychiatric Institute
New York, New York, United States, 10032
2
Nathan Kline Institute
Orangeburg, New York, United States, 10962