| NCT ID | NCT04770584 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-09-09 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-09-09 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to study how the brain learns to avoid certain stimuli or situations using an experimental paradigm. The big goal is to measure brain responses and subject's feelings and expectations when they are learning to actively avoid experimental stimuli, and how fear extinction learning and monetary cost can change how and when subjects are to avoid.
Eligibility Criteria
Inclusion Criteria: 1. 18 - 70 years of age 2. Female or Male 3. Inclusion Criteria: PTSD Subjects a. Diagnosis of current PTSD 4. Inclusion Criteria: Trauma-exposed healthy controls (TEHC) 1. SCID diagnosis consistent with no current psychiatric disorders, and no current PTSD 2. History of trauma exposure 5. Inclusion Criteria: Healthy controls (HC) 1. SCID diagnosis consistent with no current psychiatric disorders ("Axis I" disorders). 2. No history of trauma exposure 6. Willing and able to provide informed consent. Exclusion Criteria for ALL subjects: 1. History of neurologic disease (e.g. tic disorder) 2. Current significant suicidal ideation, plan or intent or suicidal behavior in past 6 months based on CSSRS or Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily 3. History of seizure or significant head trauma 4. History of the serious/significant psychiatric diagnosis ("Axis I" disorders) 5. Use of neuroleptics within one year prior to study 6. Current substance use (assessed by urine toxicology; positive urine toxicology screen for any substance, with the exception of THC). Per PI judgement and approval: if urine toxicology is positive for a substance, participant may be eligible to proceed with study provided their urine toxicology (or saliva test for THC) is negative at experimental visit(s) 7. Pregnancy (to be ruled out by urine ß-HCG) 8. Metallic implants or devices contraindicating magnetic resonance imaging 9. High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process Additional exclusion criteria for Trauma-exposed healthy controls (TEHC) group and Healthy controls (HC) group: 10. Current psychiatric diagnosis ("Axis I" diagnoses)
Contact & Investigator
Mohammed Milad, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at Houston (UTHealth Houston)
Frequently Asked Questions
Who can join the NCT04770584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04770584 currently recruiting?
Yes, NCT04770584 is actively recruiting participants. Contact the research team at Mohammed.R.Milad@uth.tmc.edu for enrollment information.
Where is the NCT04770584 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04770584 clinical trial?
NCT04770584 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Mohammed Milad, PhD at The University of Texas Health Science Center at Houston (UTHealth Houston). The trial plans to enroll 300 participants.