RECRUITING

Neurofeedback for Treatment Resistant Depression

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Conditions

Treatment Resistant DepressionNeurofeedbackmajor depressive disordertreatment resistantamygdala

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the clinical efficacy of real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories in patients with depression who are considered treatment-resistant

Official Title

Amygdala RtfMRI Neurofeedback for Treatment Resistant Depression

Quick Facts

Study Start:2018-10-22
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03428828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * must be able to give written informed consent prior to participation
  3. * must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test
  4. * must have a SHAPS score \> 4, indicating the presence of anhedonia
  5. * unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
  6. * previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1
  1. * have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  2. * met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
  3. * have a history of traumatic brain injury
  4. * are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  5. * are currently pregnant or breast feeding
  6. * are unable to complete questionnaires written in English
  7. * 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
  8. * 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)
  9. * have any eye problems or difficulties in corrected vision.

Contacts and Locations

Study Contact

Scott Barb
CONTACT
412-648-6809
barbsm3@upmc.edu
Kymberly Young, PhD
CONTACT
412-648-6179
youngk@pitt.edu

Principal Investigator

Kymberly Young, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
United States

Collaborators and Investigators

Sponsor: Kymberly Young

  • Kymberly Young, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-22
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2018-10-22
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Neurofeedback
  • major depressive disorder
  • treatment resistant
  • amygdala

Additional Relevant MeSH Terms

  • Treatment Resistant Depression