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Allopregnanolone for PTSD

Phase 2

Recruiting

Led By Ann M Rasmusson, MD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Posttraumatic Stress Disorder

Timeline

Screening 2 days

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial will test whether a single intravenous dose of allopregnanolone compared to placebo can help people with PTSD by promoting consolidation of extinction learning or by blocking reconsolidation of aversive memories.

Who is the study for?

This trial is for individuals with PTSD who are not at immediate risk to themselves or others, and do not have a severe traumatic brain injury, bipolar I disorder, schizophreniform disorder, or recent substance use disorder. Women must not be pregnant or breastfeeding and should agree to use two forms of birth control.Check my eligibility

What is being tested?

The study tests if an IV dose of Allopregnanolone (Allo) can help with PTSD by either making it easier to learn that something isn't scary anymore (extinction learning), or by blocking the body's stress response when remembering trauma compared to a placebo.See study design

What are the potential side effects?

Possible side effects from Allopregnanolone include risks associated with IV administration and any unknown reactions that could affect the body's normal functions. The exact side effects are not listed but may relate to how the drug affects brain processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Posttraumatic Stress Disorder.

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I have been diagnosed with Posttraumatic Stress Disorder.

Timeline

Screening ~ 2 days3 visits

Treatment ~ Varies

Follow Up ~ 1 day1 visit

Screening ~ 2 days

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 2 days for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Extinction retention in Expt. 1

Reconsolidation blockade in Expt. 2

Secondary outcome measures

Fear acquisition in Expt. 1

Fear acquisition in Expt. 2

Reinstatement of Conditioned Fear in Expt. 1

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: IV Allopregnanolone (Allo) for Extinction Retention (Expt. 1)Experimental Treatment2 Interventions

Arm 1 of Expt. 1 includes women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV Allo immediately after completion of extinction training.

Group II: IV Allo for Reconsolidation Blockade (Expt. 2)Experimental Treatment2 Interventions

Arm 1 of Expt. 2 will include women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV Allo immediately after reactivation of the conditioned fear memory by exposure to one conditioned stimulus (CS+).

Group III: IV Placebo for Extinction Retention (Expt. 1)Placebo Group2 Interventions

Arm 2 of Expt. 1 includes women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV placebo immediately after completion of extinction training.

Group IV: IV Placebo for Reconsolidation Blockade (Expt. 2)Placebo Group2 Interventions

Arm 2 of Expt. 2 will include will include women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV placebo immediately after reactivation of the conditioned fear memory by exposure to one conditioned stimulus (CS+).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,443 Total Patients Enrolled

Boston UniversityLead Sponsor

454 Previous Clinical Trials

9,941,314 Total Patients Enrolled

Ann M Rasmusson, MDPrincipal InvestigatorBoston University School of Medicine, Dept of Psychiatry

Media Library

3-day differential fear conditioning, extinction, and extinction retention testing paradigm (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04468360 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: IV Placebo for Extinction Retention (Expt. 1), IV Placebo for Reconsolidation Blockade (Expt. 2), IV Allopregnanolone (Allo) for Extinction Retention (Expt. 1), IV Allo for Reconsolidation Blockade (Expt. 2)

Post-Traumatic Stress Disorder Clinical Trial 2023: 3-day differential fear conditioning, extinction, and extinction retention testing paradigm Highlights & Side Effects. Trial Name: NCT04468360 — Phase 2

3-day differential fear conditioning, extinction, and extinction retention testing paradigm (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468360 — Phase 2

Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04468360 — 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 of eligibility for this experiment extending beyond 55 years?

"Individuals aged 18 to 55 years old are eligible for this trial; by contrast, 46 trials seek patients younger than 18 and 330 studies target those over 65."

Answered by AI

What are the criteria for joining this clinical experiment?

"This clinical trial seeks 256 people aged between 18 and 55 with Posttraumatic Stress Disorder. Candidates should also be experiencing stress symptoms to qualify for the study."

Answered by AI

What are the fundamental goals of this clinical experiment?

"This trial will span three days, with the primary objective of assessing extinction retention during Experiment 1. Secondary objectives include evaluating reinstatement of conditioned fear in Experiment 2 (measured by subtracting average SCR to last 5 CS- trials from average SCR on last 5 CS+ trials) and measuring acquisition of conditioned fear in Experiments 1 & 2 through differential SCRs or FPS scores depending on context."

Answered by AI

What is the sample size of this medical experiment?

"Affirmative. According to clinicaltrials.gov, this scientific trial is currently enlisting participants and was initially posted on March 4th 2022. The investigation has been updated as recently as May 23rd 2022 and 256 patients are needed from 2 locations."

Answered by AI

Are there any other experiments employing the three-day disparate dread conditioning, extinction, and conservation assessment model?

"The 3-day differential fear conditioning, extinction and retention testing paradigm was first reviewed in 2019 at the VA Connecticut Healthase System. Since then, 12 trials have been concluded while 5 still remain ongoing; a majority of these experiments are taking place within Boston, Massachusetts."

Answered by AI

Is the three-day differential fear conditioning, extinction, and extinction retention testing procedure safe for participants?

"Assigned a score of 2, the safety rating for 3-day differential fear conditioning, extinction, and extinction retention testing paradigm is based on prior Phase 2 clinical data that provides some reassurance but does not yet confirm efficacy."

Answered by AI

Are there any openings in this research project to participate?

"Clinicaltrials.gov has confirmed that this trial is in the process of recruiting participants, having been posted on March 4th 2022 and last updated on May 23rd 2022."

Answered by AI