| Eligibility |
Inclusion Criteria:
- Meets criteria for current Posttraumatic Stress Disorder (PTSD), as per a total score
of =33 on the PTSD Checklist (PCL-5) and Diagnostic and Statistical Manual of Mental
Disorders-Fifth Edition (DSM-5) criteria for PTSD.
- Meets DSM-5 standards of chronic insomnia disorder, as follows: a. Complains of
dissatisfaction with nighttime sleep in the form of difficulty falling asleep
(subjective sleep onset latency =30 minutes), difficulty staying asleep (subjective
time awake after sleep onset =30 minutes), and/or awakening earlier in the morning
(=30 minutes before scheduled wake time and before a total sleep time of 6.5 hours)
than desired. b. Insomnia frequency of =3 times per week c. The duration of the
insomnia complaint is =3 months d. Associated with complaint of daytime impairment.
- Insomnia Severity Index total score =15 (moderate insomnia).
- Willing to not start a concurrent behavioral or other treatment program for insomnia,
PTSD, or other psychiatric disorders during the participation in the study.
- Women of child-bearing potential who are sexually active agree to use two methods of
contraception for the duration of the study and extending to 30 days after the last
dose of study drug.
Exclusion Criteria:
- Current or a history of a primary psychotic disorder (i.e., schizophrenia,
schizoaffective or bipolar disorder)
- Active suicidal or homicidal ideation requiring crisis intervention
- Current moderate or severe alcohol or marijuana use disorder, or other illicit use
disorder of any severity
- A history of moderate or severe traumatic brain injury or other neurological illness
(i.e., stroke, epilepsy, multiple sclerosis);
- Caffeine use that is deemed excessive and is contributing to the insomnia per the
opinion of the investigators (i.e. caffeinated beverages consumed after 18:00 3
times/week or more and/or that correlates with the timing of the insomnia complaints).
- Tobacco use before bedtime that is contributing to the insomnia per the opinion of the
investigators or that would interfere with completing an overnight polysomnogram.
- Previous diagnosis of periodic limb movement disorder, restless legs syndrome,
circadian rhythm sleep disorder, narcolepsy, Rapid Eye Movement Behavior Disorder, or
other sleep disorders (except obstructive sleep apnea) that may confound, per the
opinion of the investigators, the assessment of insomnia.
- Previous diagnosis of moderate to severe obstructive sleep apnea (defined as an AHI
equal to or greater than 15)
- Participants deemed to be at high risk of moderate to severe obstructive sleep apnea
per the Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age,
Neck circumference, and male Gender questionnaire (STOP-BANG). Subjects with a
STOP-BANG score of 5 or greater, or STOP score of 2 or greater plus body mass index
greater than 35 kg/m2 or male or neck circumference greater than 40 cm, are considered
to be high-risk. These participants can re-enter the study following adherence to
therapy for 1-month and if inclusion and exclusion criteria are still met.
- Participants identified as having moderate to severe obstructive sleep apnea during
the screening polysomnogram. These participants will be referred to clinical treatment
- Periodic limb movement arousal index 15 or greater or other sleep disorders captured
during the screening polysomnogram that may confound, per the opinion of the
investigators, the assessment and treatment of insomnia
- A prolonged QT interval, corrected for heart rate (QTc), at the screening
electrocardiogram. A prolonged QTc is defined as 470 milliseconds for males and 480
milliseconds for females.
- Engagement in an evidence-based psychotherapy for 1-week prior to enrollment that in
the opinion of the investigators, may confound the assessment of insomnia
- Current evidence of clinically significant cardiac, respiratory, gastrointestinal,
renal, neurological, hepatic, and/or chronic pain that in the opinion of the
investigator(s) could affect the participant's safety or interfere with the study
assessments
- Females who are breastfeeding or pregnant at screening
- Females of childbearing potential who are not practicing acceptable pregnancy
prevention methods (NOTE: All females will be considered to be of childbearing
potential unless they are postmenopausal or have been sterilized surgically).
- Current use of a prohibited medications: Hypnotic or sedating medications taken at
bedtime for insomnia; antipsychotics and antidepressants with known 5HT2A antagonist
activity; medications that increase or decrease the metabolism of pimavanserin;
medications that increase the risk of QTc prolongation
- Patients with conditions known to increase the risk of torsades de pointes and/or
sudden death, such as symptomatic bradycardia and other cardiac arrhythmias,
uncorrected hypokalemia or hypomagnesemia, and congenital prolongation of the QT
interval.
|
