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Dual Orexin Receptor Antagonist

Suvorexant for PTSD-Related Sleep Disturbances

Phase 4

Recruiting

Led By Sabra S Inslicht, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control

Be older than 18 years old

Must not have

Manic or psychotic episode in the last 5 years

Prohibited medications: benzodiazepines, strong CYP3A inhibitors, Digoxin, CNS depressants when co-administered with suvorexant, and concomitant use of suvorexant with specific inhibitors or inducers of CYP3A

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 1 week at baseline, and weeks 4, 8, and 12

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will test whether suvorexant, a drug that reduces orexin, can improve sleep disturbances and PTSD symptoms in Veterans.

Who is the study for?

This trial is for US Veterans aged 18-75 with PTSD and sleep disturbances, not currently experiencing severe mental health crises or substance abuse. Participants must have stable medication use if applicable, no recent trauma exposure, and cannot be pregnant or planning pregnancy.

What is being tested?

The study tests Suvorexant's effectiveness in improving sleep and reducing PTSD symptoms compared to a placebo. It explores whether targeting the orexin system can provide relief with fewer side effects than previous treatments.

What are the potential side effects?

Suvorexant may cause drowsiness, headaches, dizziness, dry mouth, coughing or wheezing; however it aims to present fewer side effects than earlier medications used for these conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant, planning to become pregnant, or breastfeeding, and I will use birth control.

Exclusion Criteria

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

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I have not had a manic or psychotic episode in the last 5 years.

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I am not taking benzodiazepines, strong CYP3A inhibitors, Digoxin, CNS depressants with suvorexant, or specific CYP3A affecting drugs.

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I have been diagnosed with narcolepsy.

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I am currently taking benzodiazepines, strong CYP3A inhibitors, or Digoxin.

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I have not had serious thoughts or actions of harming myself or others in the last 3 months.

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I have a brain disorder or illness affecting my brain function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 1 week at baseline, and weeks 4, 8, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from 1 week at baseline, and weeks 4, 8, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 1 week at baseline, and weeks 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Insomnia Severity Index (ISI)

Secondary study objectives

Post-Traumatic Stress Disorder

Wrist Actigraphy

Other study objectives

Clinical Global Impression (CGI)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SuvorexantExperimental Treatment1 Intervention

Suvorexant is a dual orexin receptor antagonist that is FDA approved to treat insomnia.

Group II: Identical PlaceboPlacebo Group1 Intervention

Visibly matched, equally weighted placebo tablets. In addition to matching in appearance and weight, they will have identical packaging and labeling as randomized, blinded study medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Suvorexant

2016

Completed Phase 4

~2200

0 / 7Eligibility criteria met