Last reviewed · How we verify
NCT04809116
Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept
Phase 4 trial testing Pimavanserin in Insomnia Chronic. Withdrawn.
15 December 2023
Quick facts
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 15 December 2022 |
| Primary completion | 15 December 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pimavanserin (PIMAVANSERIN) — full drug profile →
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
Sponsor
Baylor College of Medicine
Who can join
Adults 18 to 64, any sex, with Insomnia Chronic or Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
Verify or expand the search:
- PubMed search for NCT04809116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pimavanserin
Trials testing the same drug.
- NCT06592833 — Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder · Phase 2 · recruiting
- NCT05796167 — Pimavanserin for Sleep in Parkinson Disease · EARLY_PHASE1 · withdrawn
- NCT05555615 — Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder · Phase 2, PHASE3 · terminated
- NCT04373317 — Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis · Phase 4 · recruiting
- NCT05523895 — Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder · Phase 2, PHASE3 · completed
Other recruiting trials for Insomnia Chronic
Currently open trials in the same condition.
- NCT07387406 — Sleep Learning Education and Empowerment for Older Korean Immigrants · NA · recruiting
- NCT07089797 — Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers · NA · recruiting
- NCT06736548 — Sleep Treatment Education Program for Cancer Survivors: STEP-Together · NA · recruiting
- NCT06926348 — Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample · NA · recruiting
- NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
Other Baylor College of Medicine trials
Trials by the same sponsor.
- NCT07513194 — GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT) · Phase 1 · not yet recruiting
- NCT05855824 — Toddler Biomarker of Nutrition Study · NA · not yet recruiting
- NCT06738628 — Disposable Endoscope Platform in Third Space Endoscopic Procedures · not yet recruiting
- NCT06834997 — Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital · Phase 2 · withdrawn
- NCT07387614 — WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04809116 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
- Last refreshed: 24 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04809116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing