Suvorexant and Trauma Related Insomnia

NCT02704754 | Completed Phase 4 Results

• 1 other identifier: GHUCCTS2015-1333
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Problems sleeping are common after exposure to highly threatening experiences and can occur with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments for PTSD are limited for addressing insomnia and many insomnia treatments appear to be limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved drugs has a unique mechanism of action that may be well suited for targetting arousal at night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for insomnia that developed in relation to trauma exposure, utilizing a placebo control, and polysomnography to identify biomarkers of response, in a six week trial.

Conditions

Insomnia; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index Score From Baseline.

  A seven-item measure used to evaluate insomnia severity for the preceding two weeks. Items are scored on a 5-point scale and a total score ranging between 0 and 28 is obtained by summing the seven items, with higher scores indicating greater insomnia severity.

  Baseline score minus 6 weeks or last observation (measure was also obtained at 2 and 4 weeks, the mathematical mean for the "last observation" was 5 weeks).

Secondary Outcomes (2)

• Change in Clinician Administered PTSD Scale Score

  Baseline score minus 6 weeks or last observation (measure was also obtained at 2 and 4 weeks, the mathematical mean for the "last observation" was 5 weeks).

• Polysomnographically Measured Wake After Sleep Onset

  Baseline values minus the values at 2 weeks.

Study Arms (2)

suvorexant

EXPERIMENTAL

10mg administered before bedtime, during the first week; if well tolerated then the dose is increased to 20 mg before bedtime.

Drug: suvorexant

Placebo pill

PLACEBO COMPARATOR

A pill without active ingredients Randomization occurs 1:1 with stratification for gender and PTSD status.

Other: placebo

Interventions

suvorexant DRUG

First in class orexin antagonist recently 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 - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically healthy adults age 18-55 who meet DSM-5 criteria for insomnia and Criterion A (exposure to a traumatic event) for PTSD. The index trauma must have occurred within the past 5 years and at least 3 months before enrolling, and insomnia symptoms must have started or worsened after the exposure to the index trauma

You may not qualify if:

• Psychiatric disorders other than insomnia, PTSD and specific phobias; including bipolar and psychotic disorders and meeting criteria for DSM-5 moderate alcohol or drug use disorders within the past year.
• Diagnosis of a sleep disorder other than insomnia including PSG findings of apnea/hypopnea or periodic limb movement indices \> 10/hour;
• Medical conditions that require consistent use of medication or compromise sleep;
• History of moderate to severe traumatic brain injury or mild traumatic brain injury with ongoing post-concussive symptoms;
• 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) or a concerning history of prior suicidal behavior.
• Caffeine use exceeding 5 cups of coffee per day or its equivalent;
• Habitual bedtimes after 3 AM, habitual rise times after 10 AM, or habitual napping \> 1hour/day;
• Pregnancy or breastfeeding, or expecting to conceive while in study;
• Positive urine toxicology.

Sponsors & Collaborators

• Howard University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Clinical Research Unit; Howard University Hospital

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

Location

Related Publications (1)

• Mellman TA, Birku K, Sandhu I, Lavela P, Kobayashi I. Evaluation of suvorexant for trauma-related insomnia. Sleep. 2022 May 12;45(5):zsac068. doi: 10.1093/sleep/zsac068. Epub 2022 Mar 18.

  PMID: 35554590 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Thomas A Mellman
• Organization: Howard University

TMellman@Howard.edu

12022575961

Study Officials

• Thomas A Mellman, M.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: February 17, 2016
• First Posted: March 10, 2016
• Study Start: May 1, 2016
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: now, for 5 years
• Access Criteria: reasonable request made directly to investigator

Locations

US (1)