Improving emotion regulation in depression using real-time fMRI-based neurofeedback

Not Applicable

Completed

• Conditions: Patients diagnosed with mild to moderate unipolar depression (major depressive disorder, MDD); Mental and Behavioural Disorders

• Registration Number: ISRCTN71745131
• Lead Sponsor: niversity of Zurich

Brief Summary

2023 Results article in https://www.frontiersin.org/articles/10.3389/fnins.2023.1286665/abstract (added 29/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-01
• Study Completion: 2022-11-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Right-handed adults (18 - 65 years of age) with normal vision.
2. Primary diagnosis of unipolar depression based on DSM-IV.
3. Currently in a depressive episode with/without stable SSRI antidepressant medication or oral contraceptives and with/without co-morbid anxiety.
4. Fluent in German without any intellectual deficits (basic education completed).

Exclusion Criteria

1. Relevant Axis-1disorders: F0 (organic disorders), F1 (alcohol, opioids, etc), F2 (psychotic disorders), bipolar disorder, prominent F4 disorders (i.e., PTSD, Panic disorder), main diagnosis F6 (particularly emotionally unstable personality disorder), known F7 disorder.
2. Neurological comorbidities such as epilepsy, stroke, brain tumor, and traumatic brain injury based on the MINI Neuropsychiatric assessment.
3. Patients on antipsychotics, benzodiazepines, medications such as Temesta (>1-2 mg/day), Methadon or Haloperidol except for SSRI antidepressants.
4. Alcohol, nicotine, or other substance dependence per DSM-IV criteria.
5. MRI contraindications such as pregnancy, lactation, brain surgery, or metallic implants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depressive symptoms measured using clinician administered 21-item Hamilton Depression Rating Scale (HAMD-21) and the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-training (visit 1), post-training (visit 4) and follow-up (visit 5).