Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizophreniform, Schizoaffective Disorder, Psychosis Not Otherwise Specified (NOS)

In brief

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.

Key facts

Study ID

NCT02661347

Run by

Northwell Health

People needed

0

Starts

2016-02-01

Expected to finish

2016-12-01

Last updated by the study team

2018-03-13

Who can join

Age: 15 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.
• 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
• 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,
• age 15 to 40.
• competent and willing to sign informed consent.
• for women, negative pregnancy test and agreement to use a medically accepted birth control method.

You may not qualify if…

• serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain.
• any medical condition which requires treatment with a medication with psychotropic effects.
• significant risk of suicidal or homicidal behavior;
• cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
• medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure).
• lack of response to a prior adequate trial of risperidone.
• requires treatment with an antidepressant or mood stabilizing medication.
• presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system.
• 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.).

Where it is running

• Zucker-Hillside Hospital — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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