358
Participants
Start Date
October 24, 2022
Primary Completion Date
October 24, 2026
Study Completion Date
August 24, 2027
Pimavanserin
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).
Quetiapine
"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~Week 1 call Quetiapine: 50 mg XR QHS, Up-titration to 50 mg~Week 3 visit Quetiapine: 100 mg XR QHS, Up-titration as appropriate~Week 5 visit Quetiapine: 150 mg XR QHS, Up- or down-titration as appropriate~Week 6 call Quetiapine: 200 mg XR QHS, Up- or down-titration as appropriate"
RECRUITING
Philadelphia MultiService Center, Philadelphia, PA, Philadelphia
RECRUITING
Louis Stokes VA Medical Center, Cleveland, OH, Cleveland
RECRUITING
Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis
RECRUITING
Michael E. DeBakey VA Medical Center, Houston, TX, Houston
RECRUITING
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora
RECRUITING
VA Portland Health Care System, Portland, OR, Portland
TERMINATED
Southern Arizona VA Health Care System, Tucson, AZ, Tucson
RECRUITING
VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda
RECRUITING
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto
ACTIVE_NOT_RECRUITING
San Francisco VA Medical Center, San Francisco, CA, San Francisco
TERMINATED
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles
ACTIVE_NOT_RECRUITING
North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville
ACTIVE_NOT_RECRUITING
Edward Hines Jr. VA Hospital, Hines, IL, Hines
TERMINATED
Lexington VA Medical Center, Lexington, KY, Lexington
ACTIVE_NOT_RECRUITING
VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor
ACTIVE_NOT_RECRUITING
St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis
TERMINATED
New Mexico VA Health Care System, Albuquerque, NM, Albuquerque
TERMINATED
Syracuse VA Medical Center, Syracuse, NY, Syracuse
TERMINATED
Asheville VA Medical Center, Asheville, NC, Asheville
RECRUITING
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia
TERMINATED
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville
TERMINATED
South Texas Health Care System, San Antonio, TX, San Antonio
TERMINATED
Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond
ACTIVE_NOT_RECRUITING
VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle
VA Office of Research and Development
FED