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Trier social stress test for Mitochondrial Disease (MiSBIE Trial)

N/A
Waitlist Available
Led By Martin Picard, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 post challenge (approximately 2 hours)
Awards & highlights

MiSBIE Trial Summary

This trial will help researchers understand how mitochondrial allostatic load (MAL), or mitochondrial dysfunction, affects physical and mental health.

MiSBIE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 post challenge (approximately 2 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 post challenge (approximately 2 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average TSST-induced elevation in cortisol
Average allostatic load index
Secondary outcome measures
Heart rate
Average neuropsychological function
Correlation between anxiety and mitochondrial respiration

MiSBIE Trial Design

4Treatment groups
Experimental Treatment
Group I: Mutation with MELASExperimental Treatment1 Intervention
Participants carrying the m.3243A>G point mutation, with a diagnosis of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes)
Group II: MutationExperimental Treatment1 Intervention
Participants carrying the m.3243A>G point mutation, without a diagnosis of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes)
Group III: Healthy controlsExperimental Treatment1 Intervention
No diagnosis of mitochondrial disease
Group IV: DeletionExperimental Treatment1 Intervention
Participants carrying a single, large-scale mtDNA deletion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trier social stress test
2015
N/A
~50

Find a Location

Who is running the clinical trial?

Technische Universität DresdenOTHER
282 Previous Clinical Trials
2,271,385 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,925 Previous Clinical Trials
13,197,784 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,427 Previous Clinical Trials
2,459,740 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this research endeavor?

"Clinicaltrials.gov records indicate that this experiment, first introduced on June 12th 2018, is actively seeking participants to join. The details regarding the trial were most recently updated on July 18th 2022."

Answered by AI

Who can participate in this clinical trial?

"This clinical study is seeking 120 individuals suffering from mitochondrial diseases, aged between 18 and 55. Applicants must be willing to provide saliva samples, have a venous catheter inserted for blood sampling, understand the implications of participating in this trial with regards to providing consent and maintain an effective birth control method if applicable; additionally all applicants should possess basic English language proficiency."

Answered by AI

Are there limitations to the number of participants enlisted in this clinical trial?

"Affirmative. Information on clinicaltrials.gov reveals that patient recruitment is ongoing for this trial, which was posted on June 12th 2018 and last updated July 18th 2022. In total, 120 participants are required at a single location."

Answered by AI

Does this research encompass participants aged 75 or above?

"Prospective participants of this research should be aged 18 and under 55."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mitochondrial Stress, Brain Imaging, and Epigenetics
Martin Picard 2018. "Mitochondrial Stress, Brain Imaging, and Epigenetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04831424.
~11 spots leftby Dec 2024
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