Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder

NCT02849548 | Completed Phase 4 Results

• 2 other identifiers: GHUCCTS2016-03771K01MH110647-01A1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score at Week 2

  A structured clinical interview used to assess posttraumatic stress disorder (PTSD) symptom severity for the preceding week. Items are scored on a 5-point scale, and a total score is obtained by summing the 20 symptom items, with higher scores indicating greater PTSD symptom severity. The total scores range from 0 - 80.

  2 weeks

Secondary Outcomes (2)

• The Baseline-corrected Highest Subjective Unit of Distress Scale (SUDS) Scores at the Last Written Narrative Exposure Session

  1 week

• The Baseline-corrected Highest Pulse Rate Across at the Last Written Narrative Exposure Session

  1week

Study Arms (2)

suvorexant

EXPERIMENTAL

10 to 20 mg to be administered after an evening written trauma narrative exposure session.

Drug: suvorexant

Placebo pill

PLACEBO COMPARATOR

A pill without active ingredients

Other: placebo

Interventions

suvorexant DRUG

First in class orexin antagonist approved by the FDA for the treatment of insomnia

Also known as: Belsomra

suvorexant

placebo OTHER

Pill with inactive ingredients

Placebo pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Howard University: lead
• Georgetown-Howard Universities Center for Clinical and Translational Science: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Clinical Research Unit; Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Ihori Kobayashi
• Organization: Howard University

ihori.kobayashi@gmail.com

202-865-7185

Study Officials

• Ihori Kobayashi, Ph.D.

  Howard University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: January 3, 2017
• Primary Completion: May 17, 2021
• Study Completion: May 19, 2021
• Last Updated: June 2, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available after the first publication is published.
• Access Criteria: Given the highly sensitive nature of the data which includes participants' mental and physical health information, we will make the de-identified data available to users only under a data-sharing agreement that: 1) the data will be used only for research purposes; 2) users will not identify any individual participant; 3) users utilize appropriate computer technology to ensure data security; and 4) users destroy or return the data after analyses are completed.

Locations

US (1)