rTMS in First Episode Psychosis

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT02131129

Run by

Indiana University

People needed

20

Starts

2014-04-30

Expected to finish

2016-12-01

Last updated by the study team

2023-04-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• IU Center for NeuroImaging — Indianapolis, Indiana, United States
• Prevention and Recovery Center for Early Psychosis — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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