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Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

Study acronym: C-SAPP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 24, 2026 → Oct 24, 2027
See other at-risk trials from VA Office of Research and Development

Record History

  1. Notable Primary completion pushed from Oct 24, 2026 to Oct 24, 2027 Completion pushed from Aug 24, 2027 to Aug 24, 2028 · Site details revised at 6 of 24 sites · Eligibility criteria shortened, about 5 wordsv19 Show 3 more changesShow less
    • Completion pushed from Aug 24, 2027 to Aug 24, 2028
    • Site details revised at 6 of 24 sites
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Primary completion date: Oct 24, 2025 to Oct 24, 2026 Completion date: Aug 24, 2026 to Aug 24, 2027 · Secondary endpoints: details revised at 3 of 4 entries · Site contacts updated at 1 of 24 sitesv18 Show 3 more changesShow less
    • Completion date: Aug 24, 2026 to Aug 24, 2027
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site contacts updated at 1 of 24 sites
  3. Minor Eligibility criteria expanded, about 114 words Study description expanded, about 264 words · Site details revised at 6 of 24 sitesv17 Show 2 more changesShow less
    • Study description expanded, about 264 words
    • Site details revised at 6 of 24 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study sites: 25 to 24v16
  5. Minor Site details revised at 11 of 25 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Site details revised at 1 of 25 sitesv14
  2. Minor Study sites: 24 to 25v13
  3. Minor Site details revised at 4 of 24 sitesv12
  4. Minor Site details revised at 2 of 24 sitesv11
  5. Minor Site details revised at 1 of 24 sitesv10
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 25 to 24v9 Show 1 more changeShow less
    • Study sites: 25 to 24
  7. Minor Primary completion date: Oct 1, 2025 to Oct 24, 2025 Completion date: Aug 1, 2026 to Aug 24, 2026 · Start date: Oct 1, 2022 to Oct 24, 2022v8 Show 2 more changesShow less
    • Completion date: Aug 1, 2026 to Aug 24, 2026
    • Start date: Oct 1, 2022 to Oct 24, 2022
  8. Notable Start date: May 1, 2022 to Oct 1, 2022 Primary completion date: May 1, 2025 to Oct 1, 2025 · Completion date: Sep 1, 2025 to Aug 1, 2026 · Eligibility criteria expanded, about 41 words · 2 morev7 Show 5 more changesShow less
    • Primary completion date: May 1, 2025 to Oct 1, 2025
    • Completion date: Sep 1, 2025 to Aug 1, 2026
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: 3 to 4
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  9. Notable Primary completion date: Oct 1, 2024 to May 1, 2025 Start date: Oct 1, 2021 to May 1, 2022 · Completion date: Jan 1, 2025 to Sep 1, 2025v6 Show 2 more changesShow less
    • Start date: Oct 1, 2021 to May 1, 2022
    • Completion date: Jan 1, 2025 to Sep 1, 2025
  10. Notable Primary completion date: Apr 1, 2024 to Oct 1, 2024 Start date: Apr 1, 2021 to Oct 1, 2021 · Completion date: Jul 1, 2024 to Jan 1, 2025v5 Show 2 more changesShow less
    • Start date: Apr 1, 2021 to Oct 1, 2021
    • Completion date: Jul 1, 2024 to Jan 1, 2025
  11. Minor Study sites: 1 to 25v4
  12. Notable Start date: Jan 1, 2021 to Apr 1, 2021 Primary completion date: Jan 1, 2024 to Apr 1, 2024v3 Show 1 more changeShow less
    • Primary completion date: Jan 1, 2024 to Apr 1, 2024
  13. Minor Eligibility criteria shortened, about 5 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't real (hallucinations) or believe things that aren't true (delusions). Hallucinations or delusions, together called psychosis, occur in up to 60% of PD patients at some point in time. Parkinson's disease psychosis can sometimes be associated with decreased quality of life, increased nursing home placement, increased rate of death, and greater caregiver burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time. Quetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that is the most commonly used medication to treat PD psychosis, but more studies are needed to determine if it works for this condition and is also well tolerated and safe. Pimavanserin is a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to treat PD psychosis, but more studies are needed to determine if it works and its safety. The purpose of this research is to gather additional information on the safety and effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators hope to learn which of these medications is the most effective course of treatment for people with PD psychosis. Enrollment is open to Veterans nationwide, see your VA provider about the possibility of being referred to one of the study's Hub sites. This can be done through contact from your provider to the study's NSC (Tamara Boney at 267-303-9829).
Trial Details
NCT Number NCT04373317
Lead Sponsor VA Office of Research and Development
Conditions Parkinson's Disease Psychosis
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov