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N/A N=20 Randomized Quadruple-blind Treatment

rTMS in First Episode Psychosis

Schizophrenia · Schizophreniform Disorder · Schizoaffective Disorder

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Cognitive Performance — 2.22; -0.50; 6.11; -3.70 BACS Composite Score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
rTMS (Device); Sham Comparator (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Cognitive Performance
0.78; -6.30; 1.11; 1.40; 11.00; 3.80
PRIMARY
Cortical Activation
0.099872925; 0.115569747
SECONDARY
Cognitive Performance
0.78; -6.30; 1.11; 1.40; 11.00; 3.80
SECONDARY
Cognitive Performance
0.78; -6.30; 1.11; 1.40; 11.00; 3.80
SECONDARY
Symptoms
-0.89; 5.60; -1.11; 6.80; 1.33; 2.00
SECONDARY
Negative Symptoms
40.67; 44.80; 46.44; 46.40; 42.22; 46.90

Summary

This study proposes to examine the application of rTMS for the treatment of cognitive dysfunction in FEP. This is an important population for study because if effective, rTMS may represent a preventative treatment for the development of social and vocational impairment that is associated with cognitive dysfunction in schizophrenia. This study will also seek to refine the understanding of the brain circuitry that mediates the potential pro-cognitive effects of rTMS through the use of functional magnetic resonance imaging (fMRI) at baseline and following the course of rTMS administration.

Eligibility Criteria

Inclusion Criteria

  • 18-40 years of age at study entry
  • Male or female
  • DSM IV-TR Diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)44
  • Subjects in their first-episode of psychosis, defined as the onset of clinically significant psychotic symptoms within the past five years as determined by first medical record documentation of these conditions
  • BACS composite t-score of 40 or less at baseline assessment
  • Clinical stability as defined by:
  • CGI-S score of less than or equal to 4 (moderately ill) at randomization AND
  • Subjects must not have experienced an exacerbation of their illness within 4 weeks prior to randomization, leading to an intensification of psychiatric care in the opinion of the investigator. Examples of intensification of care include, but are not limited to: inpatient hospitalization, day/partial hospitalization, outpatient crisis management, or psychiatric treatment in an emergency room AND
  • Antipsychotic treatment stability for at least 4 weeks prior to randomization (no change in antipsychotic dosing or addition of any new antipsychotic medication).
  • Able to give informed consent
  • Subjects must be willing and able to adhere to study schedule
  • Outpatient or Inpatient treatment status
  • Female subjects of childbearing potential must test negative for pregnancy at screening and baseline visit

Exclusion Criteria

  • Life-time history of a seizure, excluding febrile seizures and those induced by substance withdrawal
  • Metallic objects planted in or near the head, including implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt, or cochlear implants
  • First degree relative (that is, biological father, mother, brother, sister, or child) with idiopathic epilepsy or other seizure disorder
  • History of significant neurological illness (including stroke, CNS infection with persistent neurologic deficit, or other event deemed significant by PI)
  • History of head trauma as defined by a loss of consciousness or a post-concussive syndrome deemed significant by PI
  • Pregnancy or breast feeding
  • Known IQ < 70 based on medical history
  • Current DSM-IV-TR diagnosis of alcohol or drug dependence (excluding nicotine or caffeine)
  • Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, COPD, severe hypertriglyceridemia, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, or hepatic, renal gastroenterological, respiratory, endocrine, neurologic, hematologic, or infectious diseases based on medical history or physical examination.
  • Subjects with contraindications to MRI or otherwise unable to tolerate MRI procedure
  • Subjects considered a high risk for suicidal acts - active suicidal ideation as determined by clinical interview OR any suicide attempt in 90 days prior to screening
  • Subjects who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the 4 weeks prior to randomization
  • Subjects who require concomitant treatment with prohibited medication, as specified in Attachment 2
  • Subjects with a history of electroconvulsive therapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02131129). 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.

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