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NotablePrimary completion pushed from Oct 24, 2026 to Oct 24, 2027Completion pushed from Aug 24, 2027 to Aug 24, 2028 · Site details revised at 6 of 24 sites · Eligibility criteria shortened, about 5 wordsv19Show 3 more changesShow less
Completion pushed from Aug 24, 2027 to Aug 24, 2028
NotablePrimary completion date: Oct 24, 2025 to Oct 24, 2026Completion date: Aug 24, 2026 to Aug 24, 2027 · Secondary endpoints: details revised at 3 of 4 entries · Site contacts updated at 1 of 24 sitesv18Show 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
MinorEligibility criteria expanded, about 114 wordsStudy description expanded, about 264 words · Site details revised at 6 of 24 sitesv17Show 2 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 25 to 24v9Show 1 more changeShow less
Study sites: 25 to 24
MinorPrimary completion date: Oct 1, 2025 to Oct 24, 2025Completion date: Aug 1, 2026 to Aug 24, 2026 · Start date: Oct 1, 2022 to Oct 24, 2022v8Show 2 more changesShow less
Completion date: Aug 1, 2026 to Aug 24, 2026
Start date: Oct 1, 2022 to Oct 24, 2022
NotableStart date: May 1, 2022 to Oct 1, 2022Primary 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 morev7Show 5 more changesShow less
Primary completion date: May 1, 2025 to Oct 1, 2025
NotablePrimary completion date: Oct 1, 2024 to May 1, 2025Start date: Oct 1, 2021 to May 1, 2022 · Completion date: Jan 1, 2025 to Sep 1, 2025v6Show 2 more changesShow less
Start date: Oct 1, 2021 to May 1, 2022
Completion date: Jan 1, 2025 to Sep 1, 2025
NotablePrimary completion date: Apr 1, 2024 to Oct 1, 2024Start date: Apr 1, 2021 to Oct 1, 2021 · Completion date: Jul 1, 2024 to Jan 1, 2025v5Show 2 more changesShow less
Start date: Apr 1, 2021 to Oct 1, 2021
Completion date: Jul 1, 2024 to Jan 1, 2025
MinorStudy sites: 1 to 25v4
NotableStart date: Jan 1, 2021 to Apr 1, 2021Primary completion date: Jan 1, 2024 to Apr 1, 2024v3Show 1 more changeShow less
Primary completion date: Jan 1, 2024 to Apr 1, 2024
Stopped: an ongoing trial was terminated, suspended or withdrawn.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).