Neurofeedback for Treatment Resistant Depression

Launched by KYMBERLY YOUNG · Feb 9, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for adults who have depression that hasn't improved with standard medications. The researchers want to see if a technique called real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) can help these patients. This method aims to enhance the brain's response to positive memories, especially in an area of the brain called the amygdala, which is linked to emotions.

To be eligible for this study, participants need to be right-handed adults between the ages of 18 and 55 who have been diagnosed with Major Depressive Disorder and are currently experiencing depression. They should have tried at least two different antidepressant medications without success and be stable on a specific type of antidepressant called SSRIs for at least three weeks. Participants will undergo training sessions using the neurofeedback technique, and they will also complete some questionnaires to help researchers understand the treatment's effects. It's important to know that anyone with certain medical conditions, a history of substance dependence, or specific eye problems may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • right-handed adults (ages 18 - 55) with a primary diagnosis of MDD according to diagnostic criteria DSM-5 for recurrent MDD who are currently depressed will be recruited to participate
• • must be able to give written informed consent prior to participation
• • must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test
• • must have a SHAPS score \> 4, indicating the presence of anhedonia
• • unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
• • previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1
• Exclusion Criteria:
• • have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
• • met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
• • have a history of traumatic brain injury
• • are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
• • are currently pregnant or breast feeding
• • are unable to complete questionnaires written in English
• • current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
• • have a DSM-5 diagnosis of psychotic or organic mental disorder, bipolar I or II disorder or any past or current manic or hypomanic symptoms, autism, or a primary diagnosis of an anxiety disorder (though co-morbid anxiety will not be excluded)
• • have any eye problems or difficulties in corrected vision.