AnxietyNCT02954562
Correlates of Anxiety Associated With a Life-threatening Illness
An observational study of Anxiety, run by Resilient Pharmaceuticals at 1 site in United States.
Trial summary
The goal of this observational trial is to gather brain scan data on people undergoing MDMA-assisted therapy. The main question it aims to answer is: -How does brain activity change while completing an emotional regulation task in participants receiving MDMA-assisted therapy? Researchers will compare participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- fMRI
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2015to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who can safely undergo and are willing to have fMRI scans and who are enrolled in the study ""A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)"
Who may be able to join
- Enrolled in the parent study, "A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)"
Who cannot join
- Have a brain mass or lesion
- Have metal in their skulls,
- Having brain or heart pacemakers
- History of major head trauma
- Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - Berkeley
Berkeley, California, 94720
About this study
Official title: Physiological Correlates of Anxiety Associated With a Life-threatening Illness.
The goal of this observational trial is to gather brain scan data on people undergoing MDMA-assisted therapy. The main question it aims to answer is:
-How does brain activity change while completing an emotional regulation task in participants receiving MDMA-assisted therapy?
Read more
Researchers will compare participants receiving MDMA-assisted therapy to participants receiving placebo plus therapy.
Participants will undergo baseline brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task and other attentional tasks.
Participants will then undergo two medication sessions of MDMA or placebo-assisted therapy. Then, undergo another brain scan. Participants will then undergo a third medication session and repeat the brain scans.
Read the detailed description
A subset of participants in the study "Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568) without any contraindicating factors for brain imaging will undergo three fMRI scans as part of this observational study. The first scan will occur prior to experimental sessions and a second scan will occur after two experimental sessions of MDMA or placebo-assisted psychotherapy. Participants will then be scanned a third time after they have completed a total of three sessions of MDMA-assisted psychotherapy (this includes both participants that are originally in the MDMA-assisted psychotherapy group, as well as the participants in the placebo group who will cross over and complete three active MDMA-assisted psychotherapy sessions subsequent to their placebo-assisted psychotherapy). The primary endpoint will be the scan after the second experimental session.
During each scanning session, participants will be undergoing brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task that involves observing images with negative emotional valence. These images are drawn from, and have their emotional valence validated by, the International Affective Picture System (IAPS). Participants are instructed either to view passively or attempt to reduce the negative affect associated with the images. In addition, resting state brain scans will be acquired while participants fixate on a central cross with no explicit task. Heart rate variability will be measured during these resting state scans. The comparison of changes in brain activity during execution of the emotional regulation task (as compared to baseline scans) after receiving psychotherapy with MDMA or placebo, as well as comparison of changes in resting state functional connectivity, are the primary outcome measures. Study observations are intended to assess changes in response to emotion-provoking material at several levels, most notably brain activity in response to anxiety producing images.
While in the scanner, participants will also listen to prerecorded audio scripts about life stresses for themselves and for another person with instructions to practice compassion for themselves or for others. Participants will additionally perform an attentional bias task where they respond to a dot-probe that appears following a brief presentation of paired images known to produce positive and negative emotions as their brain activity is measured and their reaction times are recorded.
- Conditions
- Anxiety
- Being tested
- fMRI
- Keywords
- anxiety, fMRI, emotion regulation
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Also called Functional magnetic resonance imaging
Participants will undergo two to three fMRI scans
| Study group | Role | What they receive |
|---|---|---|
| Anxiety | Participants enrolled in study ""A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)" who meet further inclusion criteria for fMRI scan Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fMRI Blood Oxygen Level Dependent (BOLD) responses to emotional regulation task
Changes in brain activity during passive observation versus attempts to reduce negative response to images
Measured: Two months after enrollment in study NCT02427568)
Changes in fMRI Blood Oxygen Level Dependent (BOLD) resting state functional connectivity
Changes in brain activity during resting state fMRI
Measured: Two months after enrollment in study NCT02427568)
Secondary outcomes (4)
Heart rate variability (HRV) during own versus other's anxiety script
Measuring changes in speed of heart rate while listening to a personalized versus a non-personalized anxiety script.
Measured: Two months after enrollment in study NCT02427568)
Changes in fMRI BOLD response during dot probe task
Assess response to images evoking positive or negative emotion
Measured: Two months after enrollment in study NCT02427568)
Response time to dot probe task
Response time (RT) to viewing positive or negative valence images
Measured: Two months after enrollment in study MDA-1
Measure of compassion for self versus other
Compassion response listening to self-generated versus other-generated scripts
Measured: Two months after enrollment in study NCT02427568)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start7 Nov 2015
- Primary completion1 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Silver, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954562
- Sponsor's protocol ID
- MDA1-S1
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2016
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Correlates of Anxiety Associated With a Life-threatening Illness.
- ClinicalTrials.gov ID
- NCT02954562
- Acronym / sponsor ID
- MDA1-S1
- Conditions
- Anxiety
- Keywords
- anxiety, fMRI, emotion regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational trial is to gather brain scan data on people undergoing MDMA-assisted therapy. The main question it aims to answer is:
-How does brain activity change while completing an emotional regulation task in participants receiving MDMA-assisted therapy?
Researchers will compare participants receiving MDMA-assisted therapy to participants receiving placebo plus therapy.
Participants will undergo baseline brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task and other attentional tasks.
Participants will then undergo two medication sessions of MDMA or placebo-assisted therapy. Then, undergo another brain scan. Participants will then undergo a third medication session and repeat the brain scans.
Detailed description
A subset of participants in the study "Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568) without any contraindicating factors for brain imaging will undergo three fMRI scans as part of this observational study. The first scan will occur prior to experimental sessions and a second scan will occur after two experimental sessions of MDMA or placebo-assisted psychotherapy. Participants will then be scanned a third time after they have completed a total of three sessions of MDMA-assisted psychotherapy (this includes both participants that are originally in the MDMA-assisted psychotherapy group, as well as the participants in the placebo group who will cross over and complete three active MDMA-assisted psychotherapy sessions subsequent to their placebo-assisted psychotherapy). The primary endpoint will be the scan after the second experimental session.
During each scanning session, participants will be undergoing brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task that involves observing images with negative emotional valence. These images are drawn from, and have their emotional valence validated by, the International Affective Picture System (IAPS). Participants are instructed either to view passively or attempt to reduce the negative affect associated with the images. In addition, resting state brain scans will be acquired while participants fixate on a central cross with no explicit task. Heart rate variability will be measured during these resting state scans. The comparison of changes in brain activity during execution of the emotional regulation task (as compared to baseline scans) after receiving psychotherapy with MDMA or placebo, as well as comparison of changes in resting state functional connectivity, are the primary outcome measures. Study observations are intended to assess changes in response to emotion-provoking material at several levels, most notably brain activity in response to anxiety producing images.
While in the scanner, participants will also listen to prerecorded audio scripts about life stresses for themselves and for another person with instructions to practice compassion for themselves or for others. Participants will additionally perform an attentional bias task where they respond to a dot-probe that appears following a brief presentation of paired images known to produce positive and negative emotions as their brain activity is measured and their reaction times are recorded.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxiety | – | Other: fMRIParticipants enrolled in study ""A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)" who meet further inclusion criteria for fMRI scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who can safely undergo and are willing to have fMRI scans and who are enrolled in the study ""A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)"
Key inclusion criteria (1 listed)
- Enrolled in the parent study, "A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)"
Key exclusion criteria (5 listed)
- Have a brain mass or lesion
- Have metal in their skulls,
- Having brain or heart pacemakers
- History of major head trauma
- Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)
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 |
|---|---|---|
| fMRIAlso: Functional magnetic resonance imagingParticipants will undergo two to three fMRI scans | Other | Anxiety |
Primary outcome
Changes in fMRI Blood Oxygen Level Dependent (BOLD) responses to emotional regulation task
Time frame: Two months after enrollment in study NCT02427568)
Changes in brain activity during passive observation versus attempts to reduce negative response to images
Changes in fMRI Blood Oxygen Level Dependent (BOLD) resting state functional connectivity
Time frame: Two months after enrollment in study NCT02427568)
Changes in brain activity during resting state fMRI
4 secondary outcomes
Heart rate variability (HRV) during own versus other's anxiety script
Time frame: Two months after enrollment in study NCT02427568)
Changes in fMRI BOLD response during dot probe task
Time frame: Two months after enrollment in study NCT02427568)
Response time to dot probe task
Time frame: Two months after enrollment in study MDA-1
Measure of compassion for self versus other
Time frame: Two months after enrollment in study NCT02427568)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Michael Silver principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Resilient Pharmaceuticals 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 5 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in fMRI Blood Oxygen Level Dependent (BOLD) responses to emotional regulation task (time frame: Two months after enrollment in study NCT02427568)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.