Phase 4
N=27
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02849548 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score at Week 2 — 16.6; 17.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- suvorexant (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Howard University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score at Week 2 |
16.6; 17.1 | — |
| SECONDARY The Baseline-corrected Highest Subjective Unit of Distress Scale (SUDS) Scores at the Last Written Narrative Exposure Session |
18.9; 40.3 | — |
| SECONDARY The Baseline-corrected Highest Pulse Rate Across at the Last Written Narrative Exposure Session |
5.3; 4.8 | — |
Summary
The purpose of this study is to examine effects of blocking the orexin system with suvorexant after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD symptoms, and intersession habituation.
Eligibility Criteria
Inclusion Criteria
- Adult men and women (age 18 or older) who meet the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD.
Exclusion Criteria
- Medical or psychiatric conditions that require consistent use of medication that affects sleep or psychiatric symptoms, except for hormonal contraceptives
- Any persistent medical condition that affects sleep
- Inability to remember most details of the index event
- Diagnosis of a sleep disorder other than insomnia including polysomnography findings of apnea/hypopnea index > 10/hour
- Consumption of more caffeine than 5 cups of coffee/day equivalent
- Smoking > 20 cigarettes/day
- Habitual bedtimes after 3AM, habitual rise times after 10AM, or average napping > 2 hour/day in a given week
- Moderate or severe alcohol use disorder within the past 6 months or moderate or severe drug use disorder within the past year
- Positive urine toxicology for illicit drugs including cannabis
- A history of psychotic disorders or bipolar disorder
- Current depression with history of recurrent depression that precedes exposure to a traumatic event
- Suicidal ideation with intent to act or with specific plan and intent in the past 6 months [Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)] or history of a suicide attempt
- Completion of exposure-based therapy targeting the index trauma
- Pregnancy or breast feeding
- Known sensitivity or allergy to an orexin receptor antagonist
- Limited ability to read or write English.
Data sourced from ClinicalTrials.gov (NCT02849548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.