Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder

NCT04188392 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: H-45799
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.

Conditions

Post-traumatic Stress Disorder; Insomnia

Keywords

Post-traumatic Stress Disorder; Insomnia

Outcome Measures

Primary Outcomes (2)

• Recruitment Rates

  The rate of enrollment per month; goal of 6 subjects total

  Total duration of recruitment time (5.8 months)

• Retention Rates

  The number of subjects who complete the protocol in its entirety; goal of 75% of subjects enrolled into treatment

  10 weeks (overall study)

Secondary Outcomes (3)

• Mean Change in Duration of Stage N3 Sleep Pre- and Post-treatment

  6 weeks (time between baseline and closeout polysomnogram)

• Discontinuation Rates Due to Adverse Effects

  10 weeks (overall study duration)

• Completion Rates of Key Outcome Measures

  10 weeks (overall study duration)

Study Arms (1)

open-label treatment

EXPERIMENTAL

pimavanserin 34mg at bedtime for 6 weeks

Drug: Pimavanserin

Interventions

Pimavanserin DRUG

pimavanserin tablet

Also known as: Nuplazid

open-label treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

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

Interventions

pimavanserin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Melissa B Jones, MD
• Organization: Baylor College of Medicine

melissa.jones2@bcm.edu

713-791-1414

Study Officials

• Melissa B Jones, MD

  Michael E. DeBakey VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 5, 2019
• Study Start: January 6, 2020
• Primary Completion: October 27, 2021
• Study Completion: November 10, 2021
• Last Updated: August 31, 2022
• Results First Posted: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)