Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Risperidone

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.).