ISRCTN10526888已完成未知
FMRI neurofeedback treatment of self-blaming emotions in major depressive disorder – a pilot trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 43
研究概览
简要总结
2019 Preprint results in https://doi.org/10.1101/19004309 non-peer-reviewed results in preprint (added 18/03/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34852855/ (added 03/12/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Recurrent major depressive disorder (MDD) according to DSM-V with at least one major depressive episode (MDE) of at least 2 months duration, insufficiently remitted from current MDE and stable symptoms for at least 6 weeks, level of symptoms that are significantly bothering or impairing
- •2. If treated with antidepressants, on stable dose for at least 6 weeks prior participation and planning to stay on this dose for the duration of the study
- •3. Patients have insufficiently responded to at least one course of cognitive behavioural therapy (CBT) or antidepressants or are not amenable to these standard treatments and are not currently undergoing psychotherapy
- •4. Aged 18 years or over
- •5. Right-handedness
- •6. Proficient in English
排除标准
- •Exclusion criteria as of 08/08/2016:
- •1. Greater than low risk of suicidality or violence
- •2. Current MDE with a duration of more than one year
- •3. Prior specialist diagnosis of ADHD, antisocial or borderline personality disorder
- •4. Standard MRI contraindications such as exclusion of participants with any kind of non-removable ferromagnetic devices or implants due to possible dangerous effects of the MRI magnet upon metal objects in the body
- •5. History of learning disabilities or developmental disorders
- •6. Impairments of vision or hearing which cannot be corrected during the experiment
- •7. History of manic or hypomanic episodes, of schizophreniform symptoms or schizophrenia, of substance abuse, neurological disorders such as seizures, loss of consciousness following brain injury or medical disorders affecting brain function, blood flow or metabolism
- •8. Current intake of benzodiazepines, GABAergic or benzodiazepine receptor agonists
- •9. Current recreational drug use
- •10. Pregnancy
- •Original exclusion criteria:
- •1. Active suicidal thoughts or history of suicide attempts or aggression
- •2. Last MDE with a duration of more than one year
- •3. Prior specialist diagnosis of ADHD, antisocial or borderline personality disorder
- •4. Standard MRI and tDCS contraindications such as exclusion of participants with any kind of non-removable ferromagnetic devices or implants due to possible dangerous effects of the MRI magnet upon metal objects in the body
- •5. History of learning disabilities or developmental disorders
- •6. Impairments of vision or hearing which cannot be corrected during the experiment
- •7. History of manic or hypomanic episodes, of schizophreniform symptoms or schizophrenia, of substance abuse, neurological disorders such as seizures, loss of consciousness following brain injury or medical disorders affecting brain function, blood flow or metabolism
- •8. Current intake of benzodiazepines, GABAergic or benzodiazepine receptor agonists, psychostimulants (e.g. Ritalin, and Adderall), or seizure provoking medication (e.g. Bupropion and Theophylline)
- •9. History of electroconvulsive therapy (ECT)
- •10. Current recreational drug use
- •11. Pregnancy
研究者
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