Major Depressive DisorderNCT02709161
Effects of Amygdala Neurofeedback on Depressive Symptoms
A study testing real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS in people with Major Depressive Disorder, run by Kymberly Young at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical efficacy of augmenting cognitive-behavioral therapy with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- right-handed adults
- ages 18 - 55
- primary diagnosis of MDD for recurrent MDD who are currently depressed
- able to give written informed consent prior to participation
- unmedicated OR are stable on an unsuccessful antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.
Who cannot join
- clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
- alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
- history of traumatic brain injury
- unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
- currently pregnant or breast feeding
- unable to complete questionnaires written in English
Show all 9Show fewer
- current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. I
- diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
- eye problems or difficulties in corrected vision.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
The purpose of this study is to determine the clinical efficacy of augmenting cognitive-behavioral therapy with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories.
Read the detailed description
Previous research has shown that real-time fMRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's response to positive autobiographical memory recall holds therapeutic potential for treating patients with major depressive disorder (MDD), as clinically significant decreases in clinician administered and self-report measures of depression severity were observed following two rtfMRI amygdala neurofeedback sessions. Furthermore, rtfMRI amygdala neurofeedback changed emotional processing towards a positive bias. As this rtfMRI-nf procedure utilizes principles of cognitive-behavioral therapy (CBT), including restructuring thoughts and emotional processing towards the positive, the current study seeks to examine the effects of augmenting CBT with amygdala rtfMRI-nf. Specifically, the investigators plan to test the hypothesis that pretreatment with two amygdala rtfMRI-nf sessions prior to the the start of CBT will result in a higher percentage of patients who exhibit 'sudden gains' (a between session drop of at least 25% on the Beck Depression Inventory associated with better treatment response) compared to those who receive rtfMRI-nf from a parietal control region putatively not involved in emotional processing. Over the course of three years, 60 participants diagnosed with MDD and planning to start CBT will be recruited through the clinical services of the Western Psychiatric Institute and Clinic (WPIC) and through licensed CBT therapists in the Pittsburgh metropolitan area. Participants will undergo two rtfMRI-nf sessions within the two weeks prior to starting therapy. Half of the participants will receive amygdala neurofeedback and half will receive control neurofeedback. At weeks 1-3 and 9 \& 10 following the start of therapy, the participant will complete the BDI-II and the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression measure. The number of patients who meet criteria for sudden gains and the average session at which this occurred will be compared between CBT + amygdala rtfMRI-nf and CBT + control rtfMRI-nf groups. Success will suggest a new method for improving outcomes to CBT in depressed patients.
- Conditions
- Major Depressive Disorder
- Being tested
- real-time fMRI neurofeedback: Amygdala, real-time fMRI neurofeedback: HIPS
- Keywords
- neurofeedback, major depressive disorder, amygdala
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRI neurofeedback: AmygdalaDevice
Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
real-time fMRI neurofeedback: HIPSDevice
Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
| Study group | Role | What they receive |
|---|---|---|
| real-time fMRI neurofeedback: Amygdala | Experimental | Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart. Receives: Device: real-time fMRI neurofeedback: Amygdala |
| real-time fMRI neurofeedback: HIPS | Active comparator | HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart. Receives: Device: real-time fMRI neurofeedback: HIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
Measured: 10 weeks
Secondary outcomes (1)
PROMIS Item Bank v1.0 - Depression
The PROMIS depression measure is a self-report measure of depressive symptoms consisting of 8 questions. Scores can range from 0-40 with higher scores indicating greater severity of depression. The raw scores are converted to T scores with scores with a mean of 50 and a standard deviation of 10. Scores under 55 indicate no depression and scores above 70 indicate severe depression.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startOct 2016
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: The grant funding ran out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymberly Young
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Kymberly Young, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709161
- Sponsor's protocol ID
- STUDY19110101
- Other IDs
- R00MH101235
- Status last verified
- Dec 2024
- First submitted
- 10 Mar 2016
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Compere L, Siegle GJ, Lazzaro S, Strege M, Canovali G, Barb S, Huppert T, Young K. Real-time functional magnetic resonance imaging neurofeedback training of amygdala upregulation increases affective flexibility in depression. J Psychiatry Neurosci. 2023 Jun 20;48(3):E232-E239. doi: 10.1503/jpn.220208. Print 2023 May-Jun.
PubMed 37339817
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Amygdala Neurofeedback on Depressive Symptoms
- ClinicalTrials.gov ID
- NCT02709161
- Acronym / sponsor ID
- STUDY19110101
- Conditions
- Major Depressive Disorder
- Keywords
- neurofeedback, major depressive disorder, amygdala
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The grant funding ran out
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kymberly YoungUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2016 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the clinical efficacy of augmenting cognitive-behavioral therapy with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories.
Detailed description
Previous research has shown that real-time fMRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's response to positive autobiographical memory recall holds therapeutic potential for treating patients with major depressive disorder (MDD), as clinically significant decreases in clinician administered and self-report measures of depression severity were observed following two rtfMRI amygdala neurofeedback sessions. Furthermore, rtfMRI amygdala neurofeedback changed emotional processing towards a positive bias. As this rtfMRI-nf procedure utilizes principles of cognitive-behavioral therapy (CBT), including restructuring thoughts and emotional processing towards the positive, the current study seeks to examine the effects of augmenting CBT with amygdala rtfMRI-nf. Specifically, the investigators plan to test the hypothesis that pretreatment with two amygdala rtfMRI-nf sessions prior to the the start of CBT will result in a higher percentage of patients who exhibit 'sudden gains' (a between session drop of at least 25% on the Beck Depression Inventory associated with better treatment response) compared to those who receive rtfMRI-nf from a parietal control region putatively not involved in emotional processing. Over the course of three years, 60 participants diagnosed with MDD and planning to start CBT will be recruited through the clinical services of the Western Psychiatric Institute and Clinic (WPIC) and through licensed CBT therapists in the Pittsburgh metropolitan area. Participants will undergo two rtfMRI-nf sessions within the two weeks prior to starting therapy. Half of the participants will receive amygdala neurofeedback and half will receive control neurofeedback. At weeks 1-3 and 9 \& 10 following the start of therapy, the participant will complete the BDI-II and the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression measure. The number of patients who meet criteria for sudden gains and the average session at which this occurred will be compared between CBT + amygdala rtfMRI-nf and CBT + control rtfMRI-nf groups. Success will suggest a new method for improving outcomes to CBT in depressed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-time fMRI neurofeedback: Amygdala | Experimental | Device: real-time fMRI neurofeedback: AmygdalaAmygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart. |
| real-time fMRI neurofeedback: HIPS | Active comparator | Device: real-time fMRI neurofeedback: HIPSHIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- right-handed adults
- ages 18 - 55
- primary diagnosis of MDD for recurrent MDD who are currently depressed
- able to give written informed consent prior to participation
- unmedicated OR are stable on an unsuccessful antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.
Key exclusion criteria (9 listed)
- clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
- alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
- history of traumatic brain injury
- unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
- currently pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time fMRI neurofeedback: AmygdalaParticipants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories | Device | real-time fMRI neurofeedback: Amygdala |
| real-time fMRI neurofeedback: HIPSParticipants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories | Device | real-time fMRI neurofeedback: HIPS |
Primary outcome
Beck Depression Inventory (BDI-II)
Time frame: 10 weeks
The Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
1 secondary outcome
PROMIS Item Bank v1.0 - Depression
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37339817Compere L, Siegle GJ, Lazzaro S, Strege M, Canovali G, Barb S, Huppert T, Young K. Real-time functional magnetic resonance imaging neurofeedback training of amygdala upregulation increases affective flexibility in depression. J Psychiatry Neurosci. 2023 Jun 20;48(3):E232-E239. doi: 10.1503/jpn.220208. Print 2023 May-Jun.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS in people with Major Depressive Disorder, run by Kymberly Young at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI-II) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.