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New treatment option for Schizophrenia; Psychosis
Official title Brain Circuitry Therapeutics for Schizophrenia
ClinicalTrials.gov ID: NCT06341517
What this study is testing
- What it's testing
- This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Clinically stable condition judged by their treating psychiatrist
- Background antipsychotic medication treatments have remained unchanged for at least 4 weeks
You likely can't join if
- 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...
- 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) Exclusion criteria...
See the full eligibility 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
- 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...
- 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) Exclusion criteria related to MRI or TMS
- 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.)
- 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
- Impaired ability to sense heat/pain, open wounds etc.
- Increased intracranial pressure
- 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
- 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...
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)
- 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.
- 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
- Enrolment of the PI, his/her family members, employees and other dependent persons.
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.