Phase 2
N=50
Repetitive Transcranial Magnetic Stimulation for "Voices"
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00004980 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions — 5.85; 8.61 Units on a scale — p=.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- repetitive transcranial magnetic stimulation (rTMS) (Device); sham stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jan 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions |
5.85; 8.61 | .005 sig |
| SECONDARY Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions |
1.42; .15 | .002 sig |
| SECONDARY Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions |
2.84; 3.79 | .001 sig |
| SECONDARY Responder Status |
14; 4 | .01 sig |
Summary
OBJECTIVES:
I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
Inclusion criteria
- Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
- Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
- Right-handed
- At least 4 weeks on stable antipsychotic medication
Exclusion criteria
- history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
- history of epilepsy in first degree relatives
- estimated IQ less than 80
- unable to provide informed consent
- significant unstable medical condition
- current treatment with clozapine or bupropion
- cochlear implants or other metal in the head (surgical, etc.)
- history of cardiac arrhythmia
- cardiac pacemaker
- active drug or alcohol abuse within prior 6 weeks
- pregnancy
Data sourced from ClinicalTrials.gov (NCT00004980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.