Insomnia ChronicPhase 4NCT04809116
Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept
A Phase 4 study testing Pimavanserin in people with Insomnia Chronic and Posttraumatic Stress Disorder, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a proof-of-concept, open-label trial of pimavanserin 34mg at bedtime for 6 weeks in Veterans with insomnia and Posttraumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia Chronic, Posttraumatic Stress Disorder
- What is being tested?
- Pimavanserin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 15 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male and female Veterans, aged 18-64
- Determined to meet criteria for current posttraumatic stress disorder, as per the Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) and a total score of ≥33 on the PTSD Checklist (PCL-5)
- 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 and able to comply with all aspects of the protocol
- Willing to not start a concurrent behavioral or other treatment program for insomnia, PTSD, or other psychiatric disorders during the participation in the study
- If female subjects nor their partners are surgically sterile, and if they are not post- menopausal (absence of menses for at least 12 months), female subjects are considered to be of child-bearing potential. It is required that women of child-bearing potential who are sexually active agree to either refrain from sexual activity or use a two methods of contraception for the duration of the study (i.e., beginning 30 days prior to drug initiation and extending to 30 days after the last dose of study drug). The two methods should include: 1) A barrier method (e.g., condom with spermicidal gel, diaphragm with spermicide, intrauterine devices, cervical cap), and 2) One other method, including hormonal contraceptives (e.g., oral contraceptives, injectable contraceptives, contraceptive implant) or another barrier method.
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/cannabis 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, RBD, 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 and will be referred to clinical treatment
- 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 within 1-week prior to enrollment that in the opinion of the investigators, may confound the assessment of insomnia (ex. CBT for 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; 16. 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)
- Patients with cardiac conditions that in the opinion of the investigators may increase the risk of torsades de pointes and/or sudden death (ex. symptomatic bradycardia, congenital prolongation of the QT interval)
- 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
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: Open-label Pimavanserin 34mg at Bedtime for 6 Weeks for Insomnia in Veterans With Post-traumatic Stress Disorder: Proof of Concept Study
This is a proof-of-concept, open-label trial of pimavanserin 34mg at bedtime for 6 weeks in Veterans with insomnia and Posttraumatic Stress Disorder.
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 proof-of-concept study preliminarily assesses the feasibility of open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder.
- Conditions
- Insomnia Chronic, Posttraumatic Stress Disorder
- Being tested
- Pimavanserin
- Keywords
- insomnia, posttraumatic stress disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Also called Nuplazid
open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| open-label pimavanserin 34mg at bedtime for 6 weeks | Experimental | Subjects enrolled into treatment with open-label, fixed-dose 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 number of subjects enrolled into treatment per month; goal of 20 total
Measured: 7 months
Retention rates
The number of subjects completing treatment; goal of 16 (80%)
Measured: 12 months
Secondary outcomes (3)
Mean change in duration of stage N3 sleep pre- and post-treatment
The mean change in duration of stage N3 sleep from baseline polysomnogram to week-6 polysomnogram
Measured: 6 weeks
Discontinuation rates due to adverse effects
The number of subjects who discontinue the protocol due to adverse effects
Measured: 12 months
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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start15 Dec 2022 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Why it stopped: Received alternative sources of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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
- Model description
- open-label
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Responsible party
- Principal investigator, Melissa Jones, Baylor College of Medicine
- Investigators
- Melissa B Jones, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809116
- Sponsor's protocol ID
- H-48699
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pimavanserin 34mg at Bedtime for 6 Weeks for Insomnia in Veterans With Post-traumatic Stress Disorder: Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04809116
- Acronym / sponsor ID
- H-48699
- Conditions
- Insomnia Chronic, Posttraumatic Stress Disorder
- Keywords
- insomnia, posttraumatic stress disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Received alternative sources of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a proof-of-concept, open-label trial of pimavanserin 34mg at bedtime for 6 weeks in Veterans with insomnia and Posttraumatic Stress Disorder.
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 proof-of-concept study preliminarily assesses the feasibility of open-label, fixed-dose 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
- Model description
- open-label
| Arm | Type | Receives |
|---|---|---|
| open-label pimavanserin 34mg at bedtime for 6 weeks | Experimental | Drug: PimavanserinSubjects enrolled into treatment with open-label, fixed-dose pimavanserin 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 (7 listed)
- Male and female Veterans, aged 18-64
- Determined to meet criteria for current posttraumatic stress disorder, as per the Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) and a total score of ≥33 on the PTSD Checklist (PCL-5)
- 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 and able to comply with all aspects of the protocol
Key exclusion criteria (17 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/cannabis 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: Nuplazidopen-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks | Drug | open-label pimavanserin 34mg at bedtime for 6 weeks |
Primary outcome
Recruitment rates
Time frame: 7 months
The number of subjects enrolled into treatment per month; goal of 20 total
Retention rates
Time frame: 12 months
The number of subjects completing treatment; goal of 16 (80%)
3 secondary outcomes
Mean change in duration of stage N3 sleep pre- and post-treatment
Time frame: 6 weeks
Discontinuation rates due to adverse effects
Time frame: 12 months
Completion rates of key outcome measures
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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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
Baylor College of Medicine
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 Insomnia Chronic and Posttraumatic Stress Disorder, 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 7 inclusion and 17 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: withdrawn, as of the sponsor's last update on 24 Mar 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 7 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 24 Mar 2023.