Post-traumatic Stress DisorderPhase 4PIPNCT04188392
Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder
A Phase 4 study testing Pimavanserin in people with Post-traumatic Stress Disorder and Insomnia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Post-traumatic Stress Disorder, Insomnia
- What is being tested?
- Pimavanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 10 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Pilot Feasibility Study of Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder
This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.
Read the detailed description
More treatments are needed to target insomnia in Veterans with Posttraumatic Stress Disorder. There is evidence to suggest that pimavanserin, a medication approved by the Food and Drug Administration for the treatment of psychosis in Parkinson's disease, may improve deep sleep and insomnia. This study preliminary assesses the feasibility of pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder.
- Conditions
- Post-traumatic Stress Disorder, Insomnia
- Being tested
- Pimavanserin
- Keywords
- Post-traumatic Stress Disorder, Insomnia
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Also called Nuplazid
pimavanserin tablet
| Study group | Role | What they receive |
|---|---|---|
| open-label treatment | Experimental | pimavanserin 34mg at bedtime for 6 weeks Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
The rate of enrollment per month; goal of 6 subjects total
Measured: 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
Measured: 10 weeks (overall study)
Secondary outcomes (3)
Mean Change in Duration of Stage N3 Sleep Pre- and Post-treatment
The mean difference in duration of stage N3 sleep from baseline polysomnogram to week-6 polysomnogram ([Time in N3 post-treatment] - [Time in N3 at baseline polysomnogram])
Measured: 6 weeks (time between baseline and closeout polysomnogram)
Discontinuation Rates Due to Adverse Effects
The number of subjects who discontinue the protocol due to adverse effects (from either protocol or medication)
Measured: 10 weeks (overall study duration)
Completion Rates of Key Outcome Measures
The percentage of participants who complete subject and objective measures of insomnia, including sleep diaries, actigraphy, and attended polysomnography
Measured: 10 weeks (overall study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start6 Jan 2020
- Primary completion27 Oct 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Jones, Baylor College of Medicine
- Investigators
- Melissa B Jones, MD, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188392
- Sponsor's protocol ID
- H-45799
- Acronym
- PIP
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2019
- Last updated
- 31 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Patient health information will not be transmitted to collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04188392
- Acronym / sponsor ID
- PIP / H-45799
- Conditions
- Post-traumatic Stress Disorder, Insomnia
- Keywords
- Post-traumatic Stress Disorder, Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Posted 31 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.
Detailed description
More treatments are needed to target insomnia in Veterans with Posttraumatic Stress Disorder. There is evidence to suggest that pimavanserin, a medication approved by the Food and Drug Administration for the treatment of psychosis in Parkinson's disease, may improve deep sleep and insomnia. This study preliminary assesses the feasibility of pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label treatment | Experimental | Drug: Pimavanserinpimavanserin 34mg at bedtime for 6 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimavanserinAlso: Nuplazidpimavanserin tablet | Drug | open-label treatment |
Primary outcome
Recruitment Rates
Time frame: Total duration of recruitment time (5.8 months)
The rate of enrollment per month; goal of 6 subjects total
Retention Rates
Time frame: 10 weeks (overall study)
The number of subjects who complete the protocol in its entirety; goal of 75% of subjects enrolled into treatment
3 secondary outcomes
Mean Change in Duration of Stage N3 Sleep Pre- and Post-treatment
Time frame: 6 weeks (time between baseline and closeout polysomnogram)
Discontinuation Rates Due to Adverse Effects
Time frame: 10 weeks (overall study duration)
Completion Rates of Key Outcome Measures
Time frame: 10 weeks (overall study duration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Patient health information will not be transmitted to collaborators.
Related trials for Post-traumatic Stress Disorder
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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
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Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa B Jones, MD principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pimavanserin in people with Post-traumatic Stress Disorder and Insomnia, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: Total duration of recruitment time (5.8 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.