- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373317
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis (C-SAPP)
CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Daniel Weintraub, MD
- Phone Number: 5934 (215) 823-5800
- Email: daniel.weintraub@va.gov
Study Contact Backup
- Name: John E Duda, MD
- Phone Number: (215) 823-5934
- Email: john.duda@va.gov
Study Locations
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Arizona
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Tucson, Arizona, United States, 85723
- Recruiting
- Southern Arizona VA Health Care System, Tucson, AZ
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Contact:
- Tanya Lin, MD
- Phone Number: 646-825-0643
- Email: Tanya.Lin@va.gov
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Contact:
- Marivic Hansen
- Phone Number: 14635 5207921450
- Email: Marivic.Hansen@va.gov
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California
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Loma Linda, California, United States, 92357-1000
- Recruiting
- VA Loma Linda Healthcare System, Loma Linda, CA
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Contact:
- Dorothee Cole, MD
- Phone Number: 6049 909-825-7084
- Email: Dorothee.Cole@va.gov
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Contact:
- Sonia Read
- Phone Number: 2963 9098257084
- Email: Sonia.Read@va.gov
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Palo Alto, California, United States, 94304-1207
- Recruiting
- VA Palo Alto Health Care System, Palo Alto, CA
-
Contact:
- Shannon Kilgore, MD
- Phone Number: 650-858-3999
- Email: Shannon.Kilgore@va.gov
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Contact:
- Cheyenne Murphy
- Phone Number: 6504935000
- Email: Cheyenne.Murphy@va.gov
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San Francisco, California, United States, 94121
- Not yet recruiting
- San Francisco VA Medical Center, San Francisco, CA
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Contact:
- Rafael Zuzzuarregui
- Phone Number: 559-916-6794
- Email: Joserafael.Zuzuarregui@va.gov
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West Los Angeles, California, United States, 90073
- Recruiting
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Contact:
- Denise Feil, MD
- Phone Number: 48480 310-478-3711
- Email: Denise.Feil@va.gov
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Contact:
- Youssef Khattab
- Phone Number: 48176 3104783711
- Email: Youssef.Khattab@va.gov
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contact:
- Jeanne Feuerstein, MD
- Phone Number: 720-723-6205
- Email: Jeanne.Feuerstein@va.gov
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Florida
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Gainesville, Florida, United States, 32608-1135
- Not yet recruiting
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Contact:
- William Triggs, MD
- Phone Number: 106082 352-376-1611
- Email: William.Triggs@va.gov
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Illinois
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Hines, Illinois, United States, 60141-5000
- Recruiting
- Edward Hines Jr. VA Hospital, Hines, IL
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Contact:
- Gauri Khatkhate, MD
- Phone Number: 24285 708-202-8387
- Email: Gauri.Khatkhate@va.gov
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Contact:
- Caren Flood
- Phone Number: 21814 7082028387
- Email: Caren.Flood@va.gov
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Kentucky
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Lexington, Kentucky, United States, 40502
- Recruiting
- Lexington VA Medical Center, Lexington, KY
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Contact:
- John T Slevin, MD
- Phone Number: 4920 859-233-4511
- Email: John.Slevin@va.gov
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Contact:
- Michelle Hughes
- Phone Number: 5196 8592334511
- Email: Michele.Hughes2@va.gov
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Recruiting
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Contact:
- Vikas Kotagal, MD
- Phone Number: 734-647-4331
- Email: Vikaas.Kotagal@va.gov
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Contact:
- Sarah Shair
- Phone Number: 7342228635
- Email: Sarah.Shair@va.gov
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Recruiting
- Minneapolis VA Health Care System, Minneapolis, MN
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Contact:
- James Ashe, MD
- Phone Number: 5538 612-725-2000
- Email: James.Ashe@va.gov
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Contact:
- Molly Carson
- Phone Number: 5203 6127252000
- Email: Molly.Carson@va.gov
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Missouri
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Saint Louis, Missouri, United States, 63106
- Recruiting
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO
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Contact:
- Robert White, MD
- Phone Number: 314-289-7030
- Email: Robert.White7@va.gov
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Contact:
- Fahreta Hamzabegovic
- Phone Number: 3142896333
- Email: Fahreta.Hamzabegovic@va.gov
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5153
- Recruiting
- New Mexico VA Health Care System, Albuquerque, NM
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Contact:
- Sarah Pirio-Richardson, MD
- Phone Number: 505-256-2752
- Email: Sarah.Pirio-Richardson@va.gov
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Contact:
- Chelsey Smith
- Phone Number: 6340 5052651711
- Email: Chelsey.Smith@va.gov
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New York
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Syracuse, New York, United States, 13210-2716
- Recruiting
- Syracuse VA Medical Center, Syracuse, NY
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Contact:
- Dragos Mihaila, MD
- Phone Number: 315-254-5385
- Email: Dragos.Mihaila@va.gov
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Contact:
- Maryanne Roberts
- Phone Number: 3154254917
- Email: Maryanne.Roberts2@va.gov
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North Carolina
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Asheville, North Carolina, United States, 28805
- Recruiting
- Asheville VA Medical Center, Asheville, NC
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Contact:
- Eva Morgenstern, MD
- Phone Number: 5356 828-298-7911
- Email: Eva.Morgenstern@va.gov
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Contact:
- Joshua Price-Crist
- Phone Number: 5716 8282987911
- Email: Joshua.Price-Crist@va.gov
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Ohio
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Cleveland, Ohio, United States, 44106
- Recruiting
- Louis Stokes VA Medical Center, Cleveland, OH
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Contact:
- Peijun Chen
- Phone Number: 66804 216-791-3800
- Email: Peijun.Chen@va.gov
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Contact:
- Aasef Shaikh
- Phone Number: 65229 2167913800
- Email: Aasef.Shaikh@va.gov
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- VA Portland Health Care System, Portland, OR
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Contact:
- Joel Mack, MD
- Phone Number: 54521 503-220-8262
- Email: Joel.Mack@va.gov
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Contact:
- Michael Tanaka
- Phone Number: 57338 5032208262
- Email: Michael.Tanaka2@va.gov
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Recruiting
- Philadelphia MultiService Center, Philadelphia, PA
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Contact:
- James Morley, MD
- Phone Number: 215-823-5934
- Email: James.Morley@va.gov
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Contact:
- Philip Danquah
- Email: Philip.Danquah@va.gov
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Philadelphia, Pennsylvania, United States, 19104-4551
- Recruiting
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Contact:
- Daniel Weintraub, MD
- Phone Number: 5934 215-823-5800
- Email: daniel.weintraub@va.gov
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Study Chair:
- Daniel Weintraub, MD
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Tennessee
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Nashville, Tennessee, United States, 37212-2637
- Not yet recruiting
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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Contact:
- James Fang
- Phone Number: 615-873-6800
- Email: James.Fang@va.gov
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- Michael E. DeBakey VA Medical Center, Houston, TX
-
Contact:
- Aliya Sarwar, MD
- Phone Number: 713-794-7841
- Email: Aliya.Sarwar@va.gov
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Contact:
- Priscilla Bigner
- Phone Number: 7137947939
- Email: Priscilla.Bigner@va.gov
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San Antonio, Texas, United States, 78229
- Recruiting
- South Texas Health Care System, San Antonio, TX
-
Contact:
- Qinghua Liang, MD
- Phone Number: 19425 210-617-5300
- Email: Qinghua.Liang@va.gov
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Contact:
- Judith Walden
- Phone Number: 16845 2106175300
- Email: Judith.Walden@va.gov
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Virginia
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Richmond, Virginia, United States, 23249
- Recruiting
- Hunter Holmes McGuire VA Medical Center, Richmond, VA
-
Contact:
- Jessicac Lehosit, MD
- Phone Number: 6784 804-675-5000
- Email: Jessica.Lehosit@va.gov
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Contact:
- Miriam L Hirsch
- Phone Number: 8046756284
- Email: Miriam.Hirsch@va.gov
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Washington
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Seattle, Washington, United States, 98108
- Recruiting
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Contact:
- Cyrus Zabetian, MD
- Phone Number: 206-277-6167
- Email: Cyrus.Zabetian@va.gov
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Contact:
- Christina Sargent
- Phone Number: 2062776167
- Email: Christina.Sargent@va.gov
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Wisconsin
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Madison, Wisconsin, United States, 53705-2254
- Not yet recruiting
- William S. Middleton Memorial Veterans Hospital, Madison, WI
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Contact:
- Catherine Gallagher, MD
- Phone Number: 608-256-1901
- Email: Catherine.Gallagher@va.gov
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pimavanserin 34mg
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.
|
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).
|
Active Comparator: Quetiapine
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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CGI-I Psychosis
Time Frame: 8 Weeks
|
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.
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SAPS-PD
Time Frame: 8 Weeks
|
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.
|
8 Weeks
|
MDS-UPDRS III
Time Frame: 8 Weeks
|
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).
|
8 Weeks
|
Zarit Caregiver Burden Scale
Time Frame: 8 Weeks
|
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.
|
8 Weeks
|
CGI-I Parkinsonism
Time Frame: 8 Weeks
|
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.
|
8 Weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Daniel Weintraub, MD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Schizophrenia Spectrum and Other Psychotic Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Psychotic Disorders
- Parkinson Disease
- Mental Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Quetiapine Fumarate
- Pimavanserin
Other Study ID Numbers
- 2015 (American Sleep Medicine Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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