Suvorexant 3 - PE-PC

ConditionsPTSD - Post Traumatic Stress Disorder Insomnia TBI (Traumatic Brain Injury)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorNorthern California Institute of Research and Education

About this trial

The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are:

Does suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo?

Researchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans.

Participants will:

Receive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period.

Complete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18-75 years who are U.S. military Veterans; able to read/understand English and provide written informed consent;

Exposure to a DSM-5 Criterion A traumatic event;

Current PTSD, duration > 3 months, CAPS-5 total score ≥ 12

Insomnia diagnosis indicated by ISI score >14

Disqualifiers

DSM-5 alcohol, marijuana, and/or other substance use disorder in the last 3 months. Mild alcohol and marijuana use not meeting criteria for disorder permissible;

Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features;

Exposure to trauma in the last 3 months;

Prominent suicidal or homicidal ideation, any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS)83, or increased risk of suicide that necessitates additional therapy or inpatient treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

Suvorexant
Drug
Suvorexant (10-20 mg) taken orally once nightly for 8 weeks, combined with weekly Prolonged Exposure for Primary Care (PE-PC) therapy sessions. Suvorexant is an FDA-approved orexin receptor antagonist indicated for the treatment of insomnia.
Placebo
Drug
A placebo pill taken orally once nightly for 8 weeks, combined with weekly Prolonged Exposure for Primary Care (PE-PC) therapy sessions. The placebo is a look-alike substance that contains no active drug and is used as a comparator to evaluate the efficacy of suvorexant.
Prolonged Exposure Therapy for Primary Care (PE-PC)
Behavioral
Prolonged Exposure for Primary Care (PE-PC) is a briefer version of traditional Prolonged Exposure (PE) therapy, delivered in weekly sessions over 8 weeks. PE-PC is designed to treat PTSD symptoms and related conditions such as insomnia and depression. All study participants will receive PE-PC therapy regardless of their assigned intervention arm (suvorexant or placebo).

Treatment groups

142 Participants

are divided into 2 treatment groups

Group A: PE-PC + SuvorexantActive comparator 2 interventions

Group B: PE-PC + PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Change from Baseline in PTSD Symptom Severity as Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 4, Week 8, and 6 Months

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item clinician-administered interview measuring the frequency and intensity of PTSD symptoms. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.

Time frame

Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks.

Change from Baseline in Overall Functioning as Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at Week 4, Week 8, and 6 Months

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item self-administered measure assessing functional ability across six domains. Summary scores range from 0 to 100, with higher scores indicating greater disability.

Time frame