Correlates of Anxiety Associated With a Life-threatening Illness

NCT02954562 | Completed

• 1 other identifier: MDA1-S1
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anxiety

Keywords

anxiety; fMRI; emotion regulation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Two months after enrollment in study NCT02427568)

Secondary Outcomes (4)

• Heart rate variability (HRV) during own versus other's anxiety script

  Two months after enrollment in study NCT02427568)

• Changes in fMRI BOLD response during dot probe task

  Two months after enrollment in study NCT02427568)

• Response time to dot probe task

  Two months after enrollment in study MDA-1

• Measure of compassion for self versus other

  Two months after enrollment in study NCT02427568)

Study Arms (1)

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

Other: fMRI

Interventions

fMRI OTHER

Participants will undergo two to three fMRI scans

Also known as: Functional magnetic resonance imaging

Anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)"

You may qualify if:

• 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)"

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

University of California - Berkeley

Berkeley, California, 94720, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Michael Silver

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 3, 2016
• Study Start: November 7, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 30, 2017
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)