Brain Circuitry Therapeutics for Schizophrenia

Korábbi kezelés

• Metallic objects/implants (excluding dental fillings) unless cleared to be MRI compatible (i.e. MRI compatible joint replacement)
• Any implants controlled by physiological signs in/near the head
  • Pacemaker
  • Implanted medication pump
  • Vagal nerve stimulator
  • Deep brain stimulator or TENS unit
  • Ventriculo-peritoneal shunt
  • Cochlear implant
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation.
• Previous enrolment into the current investigation

Más betegség

• History of fainting spells of unknown or undetermined aetiology that might constitute seizures
• History of multiple seizures or diagnosis of epilepsy
• Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease
• Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Intracranial lesion, from a known genetic disorder or from acquired neurologic disease (e.g. stroke, tumor, cerebral palsy, severe head injury, or significant dysmorphology).
• History of head injury resulting in prolonged loss of consciousness (>15minutes) or neurological sequelae
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, intellectual retardation, dementia, etc. of the subject
• Having legal obligation for psychiatric treatment.

Egyéb

• Impaired ability to sense heat/pain, open wounds etc.
• Increased intracranial pressure
• Ongoing pregnancy and breastfeeding. All participants capable of becoming pregnant will be required to have active contraception; any participant who is pregnant or breastfeeding will not be enrolled in the study.
  • Other exclusion criteria
• Enrolment of the PI, his/her family members, employees and other dependent persons.

• Inclusion criteria
  • Capable of giving informed consent as evaluated by the treating psychiatrist
  • Informed Consent signed by the subject
  • Patients aged 18 - 65 years diagnosed with a schizophrenia spectrum disorder (including schizophrenia, schizoaffective or non-organic psychosis, psychotic disorder NOS) according to DSM-5 criteria
  • Clinically stable condition judged by their treating psychiatrist
  • Background antipsychotic medication treatments have remained unchanged for at least 4 weeks
  • No hospitalization in acute psychiatry ward at least 3 months prior to study entry
  • Specific exclusion criteria related to psychopathology
• Comorbid and clinically active current major depressive episode determined by the treating psychiatrist.
• Active psychotic symptoms. In particular, patients that at Baseline have a PANSS scores of more than 4 in any of the following PANSS items: delusions, suspiciousness/persecution and hallucinatory behaviour will be considered not stable enough to participate.
• Significant extrapyramidal side-effects quantified by total score of mSAS > 12.
• Increased sedation due to use of medication (slowing, drowsiness, slurred speech etc.)
• Active daily use of substances (i.e. cocaine), including for therapeutically medical purposes (e.g., methadone substitution)