NCT05455827Completed
Using Functional MRI Neurofeedback to Modulate Self-blame in Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 7 Aug 2024
Brief summary (registry, in English)
To determine the feasibility of functional MRI neurofeedback in reducing overgeneralised self-blame in patients with depression
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 29 Jun 2022
- Start date
- 28 Feb 2023
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Brighton & Sussex Medical School
- Diseases
- Depression
- NCT number
- NCT05455827
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 28 Feb 2023 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Standard reasons for being unable to undergo MRI (e.g. metal implants)
- Prior specialist diagnosis of attention deficit hyperactivity disorder (ADHD), antisocial or borderline personality disorder
- Current recreational drug use
Other illness
- History of manic or hypomanic episodes, or schizophreniform or schizophrenia symptoms, or substance abuse
- History of violent behaviour or aggressive impulses
- History of neurological disorders such as seizures, loss of consciousness following brain injury or medical disorders affecting brain function, blood flow or metabolism
- History of learning disabilities, major medical, developmental or relevant other axis-I disorders
- Significant impairment of psychosocial functioning before the last MDE indicating the possibility of a comorbid personality disorder or autism spectrum disorder
Other
- Impairments of vision or hearing which cannot be corrected for during the treatment sessions
- Pregnant or breastfeeding
- Current intake of benzodiazepines, GABAergic or benzodiazepine receptor agonists
- Having MDD with the following characteristics:
- Presenting with greater than 'low-risk' suicidality, violence or current self-harming behaviour
- Experiencing a current MDE lasting more than 12 months
Who the study is looking for
- Capacity to consent. Participants will be asked to complete consent before trial begins
- Understanding of verbal and written information given in English
- Online access
- Aged 18 or over
- Male or female
- Clinical diagnosis of MDD, with the following characteristics:
- Meets Diagnostic and Statistical Manual V (DSM-V) criteria for MDD
- Experience of a previous major depressive episode (MDE) lasting at least two months (evidence of recurrent depression)
- Patients must have stable symptoms, lasting at least six weeks before experimental group randomisation
- Exhibiting at least partial treatment resistance, evidenced by insufficient response to at least one psychological intervention or antidepressant intervention
- Current use of antidepressants is not basis for exclusion, but patients must be on a stable dose for at least six weeks without improvement before the study start, and must remain at this dose throughout the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CISC, Brighton and Sussex Medical School. Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.