Schizophrenia spectrum disorder, Depressive disorder schizophrenia, schizoaffective disorder, paranoid disorder
Conditions
Interventions
Functional connectivity neurofeedback training (FCNef). Specifically, a participant is given three neuro-feedback training sessions within 2 weeks, about 45 mins per day. The brain activity of the par
Neurofeedback
Sponsors
Yoshihara Yujiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Common criteria: 1. Age at the time of enrolment is 20-60 years old. 2. Having made an informed consent on paper. Patients group: 1. Patients under treatment of the department of Psychiatry at: Kyoto University Hospital, Hiroshima University Hospital, or Institute of Science Tokyo Hospital. 2. Diagnosed as schizophrenia spectrum disorder, or depressive disorders (currently in a depressive episode) based on DSM-IV-TR, DSM-5, or DSM-5-TR. Preclinical group: 1. No current psychiatric diagnosis or its history based on SCID-5. 2. Score of Beck Depression Inventory (BDI)-II is 8 or higher.
Exclusion criteria
Exclusion criteria: 1.Under the mental state where the patient is unable to understand the purpose of the trial 2.Having a severe physical illness which hinders the patient from participating the trial 3.Restricted from taking an MRI scan due to: cardiac pacemaker, brain vascular clip, electric stimulator for neurons, implanted pump in body, remaining metallic piece in the body, tattoo, claustrophobia, pregnancy 4.Comorbidity or history of: Seizure or other disease of central nervous system, substance-related disorders, severe heart disease 5.Brain injury with loss of consciousness 6.Under treatment with drugs known to affect cognitive function such as methamphetamine, etc. (except for anticholinergics and benzodiazepines) 7.History of previous electro-convulsive therapy, transcranial magnetic stimulation, or neurofeedback training within one year. 8.Other patients who will have difficulty in completing the clinical research, patients who may suffer disadvantages due to participation in the clinical research, or patients whose safety during the clinical period will be difficult to ensure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of symptom change from the baseline after FCNef. Assessment of the symptom is done by HAM-D and BDI-II for patients with depressive disorder and subclinical group, by PANSS and BE-PSD-J for patients with schizophrenia spectrum disorder. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Assessment (selected from below according to target symptom of FCNef) Subclinical group: RRS, GAD-7, STAI, SHAPS, PANAS, PHQ-9, EQ-5D, WHO-5, GHQ-12, PSQI, ISI, HAS, SWLS, ULS, DAS24, CANTAB, BACS, TMT, RBMT, WMS-R Patients with depressive disorder: RRS, GAD-7, STAI, SHAPS, PANAS, PHQ-9, EQ-5D, WHO-5, GHQ-12, PSQI, ISI, HAS, SWLS, ULS, DAS24, BE-PSD, GAF, BACS, TMT, RBMT, WMS-R Patients with schizophrenia spectrum disorder: GAF, GAD-7, STAI, SHAPS, Apathy scale, WHO-5, GHQ-12, PSQI, ISI, SWLS, ULS, JSQLS, BACS, TMT, RBMT, WMS-R Safety: The frequency, rate, and severity of adverse events will be assessed. | — |
Contacts
Public ContactTakahiko Kawashima
Kyoto University Hospital
Outcome results
None listed