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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

Must not have

Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable)

Timeline

Screening 2 days

Treatment Varies

Follow Up 1 day

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a moderate to severe brain injury.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Extinction retention in Expt. 1

Reconsolidation blockade in Expt. 2

Secondary study objectives

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 / 3Eligibility criteria met