First Episode Psychosis: TMS-EEG predicting treatment response
Overview
About the study Around 1 in 3 people diagnosed with psychosis do not improve with antipsychotic medications, but there is currently no way of knowing when this will happen. This project will study how people with psychosis respond to medications by measuring specific brain chemicals and tests of thinking abilities. We hope that the findings of this study may help us to know more about the response to antipsychotic medications and improve antipsychotic treatments, so that patients do not have to try ineffective medications. 2. What will it involve? This study has 3 visits: 1) Screening to establish eligibility for participation (around 1 hour 30 minutes). 2) Cognitive testing to measure thinking abilities (around 3 hours and 30 minutes). 3) TMS-EEG: a harmless and painless method that generates a magnetic field to measure brain chemical activity through an elastic cap with small electrodes worn on the head (around 3 hours). 3. Who are we looking to recruit? • Diagnosis of psychosis within the last 3 years • No change in medication within the last 3 months • Aged 18-55 • Right handed 4. Rewards and expenses A total of £105 for participating in the study. We will additionally cover travel expenses and provide lunch / refreshments during the study visits.
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Planned end date
08 Jan 2027 13:28Conditions
Psychosis - First EpisodeInclusion Criteria
"First Episode Psychosis (FEP) patient inclusion criteria: FEP diagnosis; experiencing psychotic symptoms for ≤ 36 months Males or females Aged between 18-55 Right-handed, as per Edinburgh Handedness Inventory Outpatient with no hospitalisation for worsening of psychosis disorder within at least 3 months prior to screening visit Stable on current AP treatment for at least 3 months prior to screening visit AP monotherapy with atypical antipsychotics (aripiprazole, asenapine, brexpiprazole, cariprazine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) Non-responders will have: i) a score of at least 4 (moderate) on at least two positive symptom items of the Positive and Negative Syndrome Scale (PANSS) and ii) at least two prior AP trials of at least 4-6 weeks duration with inadequate clinical improvement [1] Responders will have a score of 3 or less on all items of the PANSS Score≤20 in Beck Depression Inventory (BDI) Physically healthy based on medical history as per interview at screening visit and medical notes Negative urine pregnancy test at screening visit Capacity to give written informed consent Control inclusion criteria: Males or females Aged between 18-55 No personal or family history of psychotic disorder Right-handed as per Edinburgh Handedness Inventory Score≤20 in Beck Depression Inventory (BDI) Physically healthy as per interview at screening visit Negative urine pregnancy test at screening visit Capacity to give written informed consent"
Exclusion Criteria
"2. FEP patient exclusion criteria Diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit as per Mini International Neuropsychiatric Interview (MINI) and the participant’s medical notes Current treatment with Clozapine or unsuccessful trial with Clozapine in the last 3 months prior to screening visit Treatment with Central Nervous System active medications (other than antipsychotics) that may affect performance on the study-related tasks, such as benzodiazepines, sleep medications or stimulants in the last 3 months prior to screening visit Electroconvulsive therapy (ECT) in the last 6 months prior to the screening visit Severe/uncontrolled/unstable physical illnesses that may affect participation in the study or pose a risk to the participant’s safety such as, uncontrolled diabetes, asthma, hypertension, cardiac-related problems including syncopal episodes Systematic neurological disorder, including stroke, significant traumatic brain injury, epilepsy, multiple sclerosis, Parkinson's disease No significant side effects from the AP treatment, as measured by Glasgow Antipsychotic Side Effects Scale (GASS) score of ≤21 Significant head or spinal cord injury Diagnosis of migraine Pregnancy or lactation Unwillingness or inability to follow the protocol procedures Participation in research studies using brain stimulation or cognitive enhancing medications in the last 3 months prior to screening visit Contraindications to TMS as per TMS safety guidelines [48,49] including: History of epileptic seizures and/or previous or current diagnosis of epilepsy as per participant’s medical records On medications with seizure threshold lowering potential including imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, lithium, sympathomimetics. Presence of metallic hardware and /or implants that contain magnets on the skull/brain, such as intracranial ferromagnetic metal implants, cochlear implants, or medications pumps, implanted neurostimulators, such as Deep Brain Stimulators Cardiac pacemaker or intracardiac lines Presence of metal in the body On occasions where it is not possible for the protocol to be followed, e.g. due to barriers in communication, participants will not be consented into the study. Control exclusion criteria: Diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit as per Mini International Neuropsychiatric Interview (MINI) and the participant’s medical notes Treatment with Central Nervous System active medications that may affect performance on the study-related tasks, such as benzodiazepines, sleep medications or stimulants in the last 3 months prior to screening visit Severe/uncontrolled/unstable physical illnesses that may affect participation in the study or pose a risk to the participant’s safety such as, uncontrolled diabetes, hypertension, cardiac-related problems including syncopal episodes Systematic neurological disorder including stroke, significant traumatic brain injury, epilepsy, multiple sclerosis, Parkinson's disease Significant head or spinal cord injury Diagnosis of migraine Pregnancy or lactation Unwillingness or inability to follow the protocol procedures Participation in research studies using brain stimulation or cognitive enhancing medications in the last 3 months prior to screening visit Contraindications to TMS as per TMS safety guidelines including: History of epileptic seizures and/or previous or current diagnosis of epilepsy as per participant’s medical records; On medications with seizure threshold lowering potential including imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, lithium, sympathomimetics; Presence of metallic hardware and /or implants that contain magnets on the skull/brain, such as intracranial ferromagnetic metal implants, cochlear implants, or medications pumps, implanted neurostimulators, such as Deep Brain Stimulators Cardiac pacemaker or intracardiac lines; Presence of metal in the body On occasions where it is not possible for the protocol to be followed, e.g. due to barriers in communication, participants will not be consented into the study."