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Dopamine Agonist
L-DOPA for PTSD
Phase 2
Recruiting
Led By Zachary Stowe, MD
Research Sponsored by University of Wisconsin, Madison
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 up to 2 days
Awards & highlights
Study Summary
This trial will study whether increasing consolidation of extinction memories through dopamine neurotransmission can help reduce PTSD symptoms in 120 women.
Eligible Conditions
- Post Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1
Secondary outcome measures
Change in Heart Rate (HR) to trauma scripts on Day 2 compared to Day 1
Change in Skin Conductance Response (SCR) to trauma scripts on Day 2 compared to Day 1
Change in amygdala-hippocampus functional connectivity on Day 2 compared to Day 1
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 100 mg L-DOPAExperimental Treatment1 Intervention
Complete a ~40 min fMRI scan with either hearing their trauma or neutral narrative, ingest a pill (placebo or 100mg L-DOPA) upon leaving the scanner and wait in a waiting room for ~45 minutes, then undergo a 7 min resting-state fMRI scan.Participants return ~24 hours later for Day 2 fMRI, in which they will complete a single ~40-minute fMRI scan while listening to either their trauma or neutral narrative.
Group II: PlaceboPlacebo Group1 Intervention
Complete a ~40 min fMRI scan with either hearing their trauma or neutral narrative, ingest a pill (placebo or 100mg L-DOPA) upon leaving the scanner and wait in a waiting room for ~45 minutes, then undergo a 7 min resting-state fMRI scan.Participants return ~24 hours later for Day 2 fMRI, in which they will complete a single ~40-minute fMRI scan while listening to either their trauma or neutral narrative.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-DOPA
2018
N/A
~160
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,987 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,267 Total Patients Enrolled
Zachary Stowe, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can't take certain medications like water pills that could affect the quality of the images.You have a problem with drug or alcohol addiction.You are currently breastfeeding a baby.You have metal implants in your body, like screws, pins, or artificial joints that could be affected by the strong magnetic field of the MRI scanner.You have metal objects inside your body like electronic devices, surgical implants or shrapnel.You have electronic or magnetic implants, like a pacemaker, which may be affected by the study procedures.You have a heart condition.You have a condition that affects your ability to think and remember things clearly.You have a physical disability, such as being blind or deaf, that prevents you from performing the tasks required for the study.You have tattoos or permanent makeup with metallic dyes.You have peptic ulcer disease.You have chronic obstructive pulmonary disease (COPD).You have a serious medical condition, such as HIV or cancer.You have a condition that affects how you grow and learn.You currently have PTSD, and the traumatic event that caused it involved physical or sexual assault.You have fainted for more than 30 minutes in the past, according to your own report.You have a medical condition, implant, or are taking medication that could make it difficult to get clear images and make the data unreliable.You have a mental health condition called psychotic disorder.You have a mental illness called schizophrenia or other psychotic disorders.The investigator thinks you have a health condition that could be risky for you if you participate in the trial.You are in good physical health.You are currently pregnant.You are afraid of small spaces or cannot stay still in a small space.You have a serious medical condition, such as cancer.
Research Study Groups:
This trial has the following groups:- Group 1: 100 mg L-DOPA
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04558112 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age requirement for this clinical research limited to individuals under 35 years of age?
"This particular trial seeks participants aged 21 to 50. Alternatively, there are 46 trials for minors under 18 and 341 studies that accept adults over 65 years old."
Answered by AI
What conditions may be alleviated through the application of L-DOPA?
"Restless legs syndrome, carbon monoxide poisoning and parkinsonism resulting from encephalitis can all be managed with L-DOPA."
Answered by AI
What precedent exists for L-DOPA trials?
"In 2014, the first research into L-DOPA was conducted at Tel Aviv Sourasky Medical Center. That initial study has been followed by 18,445 others and there are currently 14 ongoing trials; Madison Wisconsin is particularly active in this field of research."
Answered by AI
What criteria are necessary for inclusion in this research trial?
"This research is recruiting 120 individuals, aged 21 to 50, who suffer from post-traumatic stress disorder (PTSD). To be eligible for the trial, these criteria must be met."
Answered by AI
What is the enrollment size for this clinical experiment?
"Confirmed. Data found on clinicaltrials.gov reveals that this medical study, which was initially posted on February 18th 2021, is actively searching for participants. Approximately 120 individuals need to be enrolled from two separate sites.."
Answered by AI
Has the FDA sanctioned L-DOPA for therapeutic use?
"Our team at Power gave L-DOPA a safety score of 2, since it is currently in the midst of Phase 2 trials and there is some evidence for its security but little proof to back up its efficacy."
Answered by AI
Is this research endeavor in need of new participants?
"According to clinicaltrials.gov, this research study is actively recruiting for participants. The trial was initially posted on February 18th 2021 and its details were most recently modified on November 18th 2021."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
1
What site did they apply to?
University of Texas
Why did patients apply to this trial?
I was in a head on c. I would like to get treatment for ptsd. I experienced significant trauma as a young child. And I also served as a police officer for 15 years, which exposed me to even more trauma. I also suffer from major depression and anxiety, all of which undoubtedly ties into my PTSD. CBT hasn't really been very helpful and I tried brain spotting and EMDR, neither of which offered any relief. I just want to be better before I'm too old to really appreciate it.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What is the payout?
PatientReceived 2+ prior treatments
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