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Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis (C-SAPP)

Primary Purpose

Parkinson's Disease Psychosis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pimavanserin
Quetiapine
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease Psychosis focused on measuring Pimavanserin, Quetiapine

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Veteran
  • Age 40 years or older
  • Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
  • Psychosis [with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater]
  • Stable dose of PD medications for at least 1 month
  • If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month
  • Informed other must provide informed consent and agree to attend all study visits. The informed other must be at least 18 years of age and have regular in-person contact with the patient (at least 5 days per week, and at least 4 hours per day that is spent with patient)
  • English-speaking

INFORMED OTHER

  • Age 18 years or older
  • Must have regular in-person contact with the patient (on average at least 5 days per week, and at least 4 hours per day that is spent with patient)
  • Agree to attend all study visits
  • Be able to provide informed consent
  • English-speaking

Exclusion Criteria:

  • Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
  • Treatment with an antipsychotic, including pimavanserin in the past year, except quetiapine <50 mg/day which has been discontinued for at least 1 month prior to study randomization
  • Deep brain stimulation (DBS) surgery occurring within 6 months prior or has had stimulator adjustments in the previous month
  • History of a psychotic disorder prior to PD, including schizophrenia and bipolar disorder
  • Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
  • Psychosis secondary to other toxic or metabolic disorder
  • History of long QT syndrome
  • Prolonged QTc [>450ms in men, >470ms in women] at screening
  • History of ventricular arrhythmias, or untreated or unstable atrial fibrillation/flutter
  • Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors
  • Concomitant use of drugs that prolongs the QTc interval
  • Comorbid medical condition determined too severe by SI to allow participation in clinical trial
  • Failure to tolerate quetiapine or pimavanserin previously
  • Moderate to severe PD dementia (MoCA score <13)
  • Currently enrolled in another therapeutic or interventional study
  • Nursing home placement at screening or planned placement during the study
  • Active suicidality
  • Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception

Sites / Locations

  • Southern Arizona VA Health Care System, Tucson, AZRecruiting
  • VA Loma Linda Healthcare System, Loma Linda, CARecruiting
  • VA Palo Alto Health Care System, Palo Alto, CARecruiting
  • San Francisco VA Medical Center, San Francisco, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting
  • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • North Florida/South Georgia Veterans Health System, Gainesville, FL
  • Edward Hines Jr. VA Hospital, Hines, ILRecruiting
  • Lexington VA Medical Center, Lexington, KYRecruiting
  • VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
  • Minneapolis VA Health Care System, Minneapolis, MNRecruiting
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MORecruiting
  • New Mexico VA Health Care System, Albuquerque, NMRecruiting
  • Syracuse VA Medical Center, Syracuse, NYRecruiting
  • Asheville VA Medical Center, Asheville, NCRecruiting
  • Louis Stokes VA Medical Center, Cleveland, OHRecruiting
  • VA Portland Health Care System, Portland, ORRecruiting
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PARecruiting
  • Philadelphia MultiService Center, Philadelphia, PARecruiting
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  • Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
  • South Texas Health Care System, San Antonio, TXRecruiting
  • Hunter Holmes McGuire VA Medical Center, Richmond, VARecruiting
  • VA Puget Sound Health Care System Seattle Division, Seattle, WARecruiting
  • William S. Middleton Memorial Veterans Hospital, Madison, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pimavanserin 34mg

Quetiapine

Arm Description

All participants assigned to pimavanserin will receive the FDA-approved dose of 34mg (equivalent to 40 mg pimavanserin tartrate) daily without titration; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability.

Quetiapine extended release will be titrated as shown in the following table. During the 8-week treatment phase, there is a maximum of 6 weeks for titration. Titration Schedule Visit/call Quetiapine Dose (Flexible)Quetiapine Notes Baseline visit (Visit 00)25 mg IR QHSAll participants must be up-titrated to at least 50 mg/day at week 1 Week 1 call (Visit 01)50 mg XR QHSUp-titration Week 3 visit (Visit 03)100 mg XR QHS (requiring two 50-mg quetiapine XR capsules)Up- or down-titration as appropriate based on psychosis symptoms and tolerability Week 5 visit (Visit 05)150 mg quetiapine XR QHSUp- or down-titration as appropriate based on psychosis symptoms and tolerability Week 6 call (Visit 06)200 mg quetiapine XR QHSUp- or down-titration as appropriate based on psychosis symptoms and tolerability

Outcomes

Primary Outcome Measures

CGI-I Psychosis
The Clinical Global Impressions (CGI) scale is a brief, well-established research rating tool used to quantify and track patient progress and treatment response over time. The CGI comprises two measures, one of which is Improvement (CGI-I) from the initiation of treatment. It is scored 1 to 7. The CGI-I is used to assess how much the patient's illness has improved or worsened relative to baseline when the intervention was started (1-Very much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse). The CGI-I can also be used to assess specific domains, including psychosis (this study's primary outcome) and parkinsonism (a secondary outcome). During the 8 weeks, the CGI-I (for psychosis, hereafter simply referred to as the CGI-I) will be administered to all participants at each in-person visit (3 weeks, 5 weeks, and 8 weeks following a CGI-I baseline interview) to assess clinical improvement in psychosis.

Secondary Outcome Measures

SAPS-PD
The primary assessment of change in psychosis severity is the score on the 9-item Parkinson's disease Scale for Assessment of Positive Symptoms (SAPS-PD). The SAPS-PD scale will assess positive symptoms, including hallucinations, delusions, bizarre behavior, and positive formal thought disorder. A clinical interview is used to evaluate the participant's symptoms. Items include: 1 Auditory Hallucinations; 2 Voices Conversing; 3 Somatic or Tactile Hallucinations; 4 Visual Hallucinations; 5 Global Rating of Severity of Hallucinations; 6 Persecutory Delusions; 7 Delusions of Jealousy; 8 Ideas and Delusions of Reference; and 9 Global Rating of Severity of Delusions. Each item is given a score ranging 0 to 5 (0-None, 1-Questionable, 2-Mild, 3-Moderate, 4-Marked, 5-Severe). During the 8 weeks, the SAPS-PD will be administered to all participants at each in-person visit (baseline, 3 weeks, 5 weeks, and 8 weeks) to assess symptoms of PDP and psychopharmacological response to treatment.
MDS-UPDRS III
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination; MDS-UPDRS III) has 33 scores across 18 items (each score 0-4, range of total score 0-132, with higher scores indicating more severe motor symptoms) is completed by a trained rater during an examination of the patient, and is the most commonly-used assessment of parkinsonism in clinical trials. MDS-UPDRS III includes ratings for tremor, slowness (bradykinesia), stiffness (rigidity), and gait/balance. During the 8 weeks, the MDS-UPDRS III will be administered to all participants at each in-person visit (baseline, 3 weeks, 5 weeks, and 8 weeks).
Zarit Caregiver Burden Scale
The Zarit Burden Interview (ZBI) is a 22-item self-report inventory that examines burden associated with functional/behavioral impairments and the home care situation. It was developed to measure subjective burden among caregivers of adults with dementia. The items are worded subjectively, focusing on the affective response of the caregiver. Each question is scored on a 5-point Likert scale ranging from 0 to 4 (0-Never, 1-Rarely, 2-Sometimes, 3-Frequently, 4-Nearly always). The ZBI total score ranges from 0 (low burden) to 88 (high burden), the sum of the scores from all 22 questions. Interpretation of the total scores is: 1) 0-21 little or no burden; 2) 21-40 mild to moderate burden; 3) 41-60 moderate to severe burden; and 4) 61-88 severe burden. The ZBI will be administered to all participants' informed other at baseline and treatment phase visits of Weeks 5 and 8.
CGI-I Parkinsonism
The Clinical Global Impressions (CGI) scale is a brief, rating tool used to quantify and track patient progress and treatment response over time. It was developed to be used in clinical trials on mental health to provide an assessment of the clinician's view of the patient's global functioning over time with a study medication. The CGI comprises two measures, but the one to be used in this study is Improvement (CGI-I) from the st of treatment. It is scored from 1 to 7. The CGI-I is used to assess how much the patient's illness has improved or worsened relative to baseline when the intervention was started (1-Very much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse). During the 8 weeks, the CGI-I (for parkinsonism) will be administered to all participants at each in-person visit (3 weeks, 5 weeks, and 8 weeks following a CGI-I baseline interview) to assess improvement in parkinsonism.

Full Information

First Posted
April 29, 2020
Last Updated
July 13, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04373317
Brief Title
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Acronym
C-SAPP
Official Title
CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
October 24, 2025 (Anticipated)
Study Completion Date
August 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Psychosis
Keywords
Pimavanserin, Quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two active treatments will be administered in this RCT, with 1:1 treatment assignment to either quetiapine or pimavanserin. Both active treatments are FDA-approved antipsychotics.
Masking
ParticipantCare ProviderInvestigator
Masking Description
In order to facilitate titrations, study drug will be provided in blister cards with a sufficient number of over-encapsulated drug to bridge participants to their next titration step. Each blister card will contain a one-week supply of study drug. Because dosing will be nightly, and the study will use a combination of quetiapine strengths for all protocol-specified quetiapine doses, participants in both treatment groups will take two identical capsules both of which containing the protocol-specified nightly dose. For example, if a participant is randomized to quetiapine and is up-titrated from 50 to 100 mg ER, this participant will take 2 identical capsules, each containing 50 mg of ER quetiapine. Similarly, participants randomized to pimavanserin will take two capsules every night, one containing a placebo capsule, and the other containing 34 mg of pimavanserin.
Allocation
Randomized
Enrollment
358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pimavanserin 34mg
Arm Type
Active Comparator
Arm Description
All participants assigned to pimavanserin will receive the FDA-approved dose of 34mg (equivalent to 40 mg pimavanserin tartrate) daily without titration; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability.
Arm Title
Quetiapine
Arm Type
Active Comparator
Arm Description
Quetiapine extended release will be titrated as shown in the following table. During the 8-week treatment phase, there is a maximum of 6 weeks for titration. Titration Schedule Visit/call Quetiapine Dose (Flexible)Quetiapine Notes Baseline visit (Visit 00)25 mg IR QHSAll participants must be up-titrated to at least 50 mg/day at week 1 Week 1 call (Visit 01)50 mg XR QHSUp-titration Week 3 visit (Visit 03)100 mg XR QHS (requiring two 50-mg quetiapine XR capsules)Up- or down-titration as appropriate based on psychosis symptoms and tolerability Week 5 visit (Visit 05)150 mg quetiapine XR QHSUp- or down-titration as appropriate based on psychosis symptoms and tolerability Week 6 call (Visit 06)200 mg quetiapine XR QHSUp- or down-titration as appropriate based on psychosis symptoms and tolerability
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Fixed-dose Pimavanserin - Pimavanserin is a new antipsychotic agent, and pure 5HT-2A inverse agonist, that was approved by the FDA recently (2016) for the treatment of PDP. It is the only FDA-approved medication for PDP, but is still not the first-line AP used in PD. All participants assigned to pimavanserin will receive the FDA-approved dose of 34 mg (equivalent to 40 mg pimavanserin tartrate) daily without titration up or down; however, because pimavanserin is blinded to quetiapine, participants will undergo sham titration based on tolerability (i.e., overall adverse event profile) and efficacy (i.e., improvement in severity of psychosis).
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
Flexible-dose Quetiapine - Quetiapine, which is a mixed serotonin and dopamine receptor antagonist, is by far the most commonly used AP for PDP. However, scientific evidence for the efficacy of quetiapine in PDP is almost non-existent as most of the studies were underpowered, had high drop-out rates, and possibly underdosed quetiapine. Quetiapine immediate and extended release will be titrated as shown: Baseline visit Quetiapine: 25 mg IR QHS, All participants must be up-titrated to 50 mg/day Pimavanserin: 34 mg QHS Week 1 call Quetiapine: 50 mg XR QHS, Up-titration to 50 mg Pimavanserin: 34 mg QHS Week 3 visit Quetiapine: 100 mg XR QHS, Up-titration as appropriate Pimavanserin: 34 mg QHS Week 5 visit Quetiapine: 150 mg XR QHS, Up- or down-titration as appropriate Pimavanserin: 34 mg QHS Week 6 call Quetiapine: 200 mg XR QHS, Up- or down-titration as appropriate Pimavanserin: 34 mg QHS
Primary Outcome Measure Information:
Title
CGI-I Psychosis
Description
The Clinical Global Impressions (CGI) scale is a brief, well-established research rating tool used to quantify and track patient progress and treatment response over time. The CGI comprises two measures, one of which is Improvement (CGI-I) from the initiation of treatment. It is scored 1 to 7. The CGI-I is used to assess how much the patient's illness has improved or worsened relative to baseline when the intervention was started (1-Very much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse). The CGI-I can also be used to assess specific domains, including psychosis (this study's primary outcome) and parkinsonism (a secondary outcome). During the 8 weeks, the CGI-I (for psychosis, hereafter simply referred to as the CGI-I) will be administered to all participants at each in-person visit (3 weeks, 5 weeks, and 8 weeks following a CGI-I baseline interview) to assess clinical improvement in psychosis.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
SAPS-PD
Description
The primary assessment of change in psychosis severity is the score on the 9-item Parkinson's disease Scale for Assessment of Positive Symptoms (SAPS-PD). The SAPS-PD scale will assess positive symptoms, including hallucinations, delusions, bizarre behavior, and positive formal thought disorder. A clinical interview is used to evaluate the participant's symptoms. Items include: 1 Auditory Hallucinations; 2 Voices Conversing; 3 Somatic or Tactile Hallucinations; 4 Visual Hallucinations; 5 Global Rating of Severity of Hallucinations; 6 Persecutory Delusions; 7 Delusions of Jealousy; 8 Ideas and Delusions of Reference; and 9 Global Rating of Severity of Delusions. Each item is given a score ranging 0 to 5 (0-None, 1-Questionable, 2-Mild, 3-Moderate, 4-Marked, 5-Severe). During the 8 weeks, the SAPS-PD will be administered to all participants at each in-person visit (baseline, 3 weeks, 5 weeks, and 8 weeks) to assess symptoms of PDP and psychopharmacological response to treatment.
Time Frame
8 Weeks
Title
MDS-UPDRS III
Description
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination; MDS-UPDRS III) has 33 scores across 18 items (each score 0-4, range of total score 0-132, with higher scores indicating more severe motor symptoms) is completed by a trained rater during an examination of the patient, and is the most commonly-used assessment of parkinsonism in clinical trials. MDS-UPDRS III includes ratings for tremor, slowness (bradykinesia), stiffness (rigidity), and gait/balance. During the 8 weeks, the MDS-UPDRS III will be administered to all participants at each in-person visit (baseline, 3 weeks, 5 weeks, and 8 weeks).
Time Frame
8 Weeks
Title
Zarit Caregiver Burden Scale
Description
The Zarit Burden Interview (ZBI) is a 22-item self-report inventory that examines burden associated with functional/behavioral impairments and the home care situation. It was developed to measure subjective burden among caregivers of adults with dementia. The items are worded subjectively, focusing on the affective response of the caregiver. Each question is scored on a 5-point Likert scale ranging from 0 to 4 (0-Never, 1-Rarely, 2-Sometimes, 3-Frequently, 4-Nearly always). The ZBI total score ranges from 0 (low burden) to 88 (high burden), the sum of the scores from all 22 questions. Interpretation of the total scores is: 1) 0-21 little or no burden; 2) 21-40 mild to moderate burden; 3) 41-60 moderate to severe burden; and 4) 61-88 severe burden. The ZBI will be administered to all participants' informed other at baseline and treatment phase visits of Weeks 5 and 8.
Time Frame
8 Weeks
Title
CGI-I Parkinsonism
Description
The Clinical Global Impressions (CGI) scale is a brief, rating tool used to quantify and track patient progress and treatment response over time. It was developed to be used in clinical trials on mental health to provide an assessment of the clinician's view of the patient's global functioning over time with a study medication. The CGI comprises two measures, but the one to be used in this study is Improvement (CGI-I) from the st of treatment. It is scored from 1 to 7. The CGI-I is used to assess how much the patient's illness has improved or worsened relative to baseline when the intervention was started (1-Very much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse). During the 8 weeks, the CGI-I (for parkinsonism) will be administered to all participants at each in-person visit (3 weeks, 5 weeks, and 8 weeks following a CGI-I baseline interview) to assess improvement in parkinsonism.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veteran Age 40 years or older Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria Psychosis [with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater] Stable dose of PD medications for at least 1 month If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month Informed other must provide informed consent and agree to attend all study visits. The informed other must be at least 18 years of age and have regular in-person contact with the patient (at least 5 days per week, and at least 4 hours per day that is spent with patient) English-speaking INFORMED OTHER Age 18 years or older Must have regular in-person contact with the patient (on average at least 5 days per week, and at least 4 hours per day that is spent with patient) Agree to attend all study visits Be able to provide informed consent English-speaking Exclusion Criteria: Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead Treatment with an antipsychotic, including pimavanserin in the past year, except quetiapine <50 mg/day which has been discontinued for at least 1 month prior to study randomization Deep brain stimulation (DBS) surgery occurring within 6 months prior or has had stimulator adjustments in the previous month History of a psychotic disorder prior to PD, including schizophrenia and bipolar disorder Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB) Psychosis secondary to other toxic or metabolic disorder History of long QT syndrome Prolonged QTc [>450ms in men, >470ms in women] at screening History of ventricular arrhythmias, or untreated or unstable atrial fibrillation/flutter Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors Concomitant use of drugs that prolongs the QTc interval Comorbid medical condition determined too severe by SI to allow participation in clinical trial Failure to tolerate quetiapine or pimavanserin previously Moderate to severe PD dementia (MoCA score <13) Currently enrolled in another therapeutic or interventional study Nursing home placement at screening or planned placement during the study Active suicidality Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Weintraub, MD
Phone
(215) 823-5800
Ext
5934
Email
daniel.weintraub@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
John E Duda, MD
Phone
(215) 823-5934
Email
john.duda@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Weintraub, MD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Study Chair
Facility Information:
Facility Name
Southern Arizona VA Health Care System, Tucson, AZ
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Lin, MD
Phone
646-825-0643
Email
Tanya.Lin@va.gov
First Name & Middle Initial & Last Name & Degree
Marivic Hansen
Phone
5207921450
Ext
14635
Email
Marivic.Hansen@va.gov
Facility Name
VA Loma Linda Healthcare System, Loma Linda, CA
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothee Cole, MD
Phone
909-825-7084
Ext
6049
Email
Dorothee.Cole@va.gov
First Name & Middle Initial & Last Name & Degree
Sonia Read
Phone
9098382764
Email
Sonia.Read@va.gov
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Kilgore, MD
Phone
650-858-3999
Email
Shannon.Kilgore@va.gov
First Name & Middle Initial & Last Name & Degree
Cheyenne Murphy
Phone
6504935000
Email
Cheyenne.Murphy@va.gov
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Zuzzuarregui
Phone
559-916-6794
Email
Joserafael.Zuzuarregui@va.gov
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Feil, MD
Phone
310-478-3711
Ext
48480
Email
Denise.Feil@va.gov
First Name & Middle Initial & Last Name & Degree
Youssef Khattab
Phone
3104783711
Ext
48176
Email
Youssef.Khattab@va.gov
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Feuerstein, MD
Phone
720-723-6205
Email
Jeanne.Feuerstein@va.gov
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1135
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Triggs, MD
Phone
352-376-1611
Ext
106082
Email
William.Triggs@va.gov
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gauri Khatkhate, MD
Phone
708-202-8387
Ext
24285
Email
Gauri.Khatkhate@va.gov
First Name & Middle Initial & Last Name & Degree
Caren Flood
Phone
7082028387
Ext
21814
Email
Caren.Flood@va.gov
Facility Name
Lexington VA Medical Center, Lexington, KY
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John T Slevin, MD
Phone
859-233-4511
Ext
4920
Email
John.Slevin@va.gov
First Name & Middle Initial & Last Name & Degree
Michelle Hughes
Phone
8592334511
Ext
5196
Email
Michele.Hughes2@va.gov
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Kotagal, MD
Phone
734-647-4331
Email
Vikaas.Kotagal@va.gov
First Name & Middle Initial & Last Name & Degree
Sarah Shair
Phone
7342228635
Email
Sarah.Shair@va.gov
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Ashe, MD
Phone
612-725-2000
Ext
5538
Email
James.Ashe@va.gov
First Name & Middle Initial & Last Name & Degree
Molly Carson
Phone
6127252000
Ext
5203
Email
Molly.Carson@va.gov
Facility Name
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert White, MD
Phone
314-289-7030
Email
Robert.White7@va.gov
First Name & Middle Initial & Last Name & Degree
Fahreta Hamzabegovic
Phone
3142896333
Email
Fahreta.Hamzabegovic@va.gov
Facility Name
New Mexico VA Health Care System, Albuquerque, NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Pirio-Richardson, MD
Phone
505-256-2752
Email
Sarah.Pirio-Richardson@va.gov
First Name & Middle Initial & Last Name & Degree
Chelsey Smith
Phone
5052651711
Ext
6340
Email
Chelsey.Smith@va.gov
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2716
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dragos Mihaila, MD
Phone
315-254-5385
Email
Dragos.Mihaila@va.gov
First Name & Middle Initial & Last Name & Degree
Maryanne Roberts
Phone
3154254917
Email
Maryanne.Roberts2@va.gov
Facility Name
Asheville VA Medical Center, Asheville, NC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Morgenstern, MD
Phone
828-298-7911
Ext
5356
Email
Eva.Morgenstern@va.gov
First Name & Middle Initial & Last Name & Degree
Joshua Price-Crist
Phone
8282987911
Ext
5716
Email
Joshua.Price-Crist@va.gov
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peijun Chen
Phone
216-791-3800
Ext
66804
Email
Peijun.Chen@va.gov
First Name & Middle Initial & Last Name & Degree
Aasef Shaikh
Phone
2167913800
Ext
65229
Email
Aasef.Shaikh@va.gov
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Mack, MD
Phone
503-220-8262
Ext
54521
Email
Joel.Mack@va.gov
First Name & Middle Initial & Last Name & Degree
Michael Tanaka
Phone
5032208262
Ext
57338
Email
Michael.Tanaka2@va.gov
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4551
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Weintraub, MD
Phone
215-823-5800
Ext
5934
Email
daniel.weintraub@va.gov
First Name & Middle Initial & Last Name & Degree
Daniel Weintraub, MD
Facility Name
Philadelphia MultiService Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Morley, MD
Phone
215-823-5934
Email
James.Morley@va.gov
First Name & Middle Initial & Last Name & Degree
Philip Danquah
Email
Philip.Danquah@va.gov
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Fang
Phone
615-873-6800
Email
James.Fang@va.gov
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliya Sarwar, MD
Phone
713-794-7841
Email
Aliya.Sarwar@va.gov
First Name & Middle Initial & Last Name & Degree
Priscilla Bigner
Phone
7137947939
Email
Priscilla.Bigner@va.gov
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghua Liang, MD
Phone
210-617-5300
Ext
19425
Email
Qinghua.Liang@va.gov
First Name & Middle Initial & Last Name & Degree
Judith Walden
Phone
2106175300
Ext
16845
Email
Judith.Walden@va.gov
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessicac Lehosit, MD
Phone
804-675-5000
Ext
6784
Email
Jessica.Lehosit@va.gov
First Name & Middle Initial & Last Name & Degree
Miriam L Hirsch
Phone
8046756284
Email
Miriam.Hirsch@va.gov
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrus Zabetian, MD
Phone
206-277-6167
Email
Cyrus.Zabetian@va.gov
First Name & Middle Initial & Last Name & Degree
Christina Sargent
Phone
2062776167
Email
Christina.Sargent@va.gov
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2254
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Gallagher, MD
Phone
608-256-1901
Email
Catherine.Gallagher@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

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