Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept
NCT04809116 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2023-03-24
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.
Conditions
- Insomnia Chronic
- Posttraumatic Stress Disorder
Interventions
- DRUG
-
Pimavanserin
open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks
Sponsors & Collaborators
-
ACADIA Pharmaceuticals Inc.
collaborator INDUSTRY -
Baylor College of Medicine
lead OTHER
Principal Investigators
-
Melissa B Jones, MD · Baylor College of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-15
- Primary Completion
- 2023-12-15
- Completion
- 2023-12-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
NCT03642028 ·Status: RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia
NCT00308503 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
NCT00569972 ·Status: COMPLETED ·Phase: PHASE2
-
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
NCT00506389 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
NCT00805350 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
NCT00482612 ·Status: COMPLETED ·Phase: PHASE3
-
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
NCT00631657 ·Status: COMPLETED ·Phase: PHASE3
-
Suvorexant and Trauma Related Insomnia
NCT02704754 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
NCT06644573 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
NCT00664664 ·Status: COMPLETED ·Phase: PHASE2
-
Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
NCT00177216 ·Status: COMPLETED ·Phase: PHASE4
-
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
NCT00525941 ·Status: WITHDRAWN ·Phase: PHASE3
-
Xyrem for Treatment Refractory Insomnia Due to PTSD
NCT00330291 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
NCT00655369 ·Status: COMPLETED ·Phase: PHASE2
-
A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia
NCT00606697 ·Status: COMPLETED ·Phase: PHASE2
-
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
NCT00247624 ·Status: COMPLETED ·Phase: PHASE4
-
Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia
NCT02671760 ·Status: COMPLETED ·Phase: PHASE2
-
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia
NCT03338764 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
NCT00551148 ·Status: COMPLETED ·Phase: PHASE2
-
Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder
NCT00552760 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
NCT00679900 ·Status: COMPLETED ·Phase: PHASE3
-
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
NCT00280423 ·Status: COMPLETED ·Phase: PHASE2
-
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
NCT02849548 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
NCT00711516 ·Status: COMPLETED ·Phase: PHASE4
-
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
NCT01489969 ·Status: COMPLETED ·Phase: PHASE2