Clinical Trial Search

Primary: Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score — 14.0 score on a scale — p=<0.0001

Primary: Antipsychotic Efficacy — -5.9; -5.8; -6.7; NA Score on the SAPS H+D scale

Primary: Antipsychotic Efficacy — -4.4; NA; -6.5; NA Scores on the SAPS H+D scale

Primary: Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6 — -1.4; -2.5 Units on a scale

Primary: Antipsychotic Efficacy — -2.73; -5.79; NA; -3.06 Score on the SAPS-PD scale

Primary: Patient Evaluation of Symptoms of Psychosis. — -9.8; -12.9; -9.7; -10.0 Scores on a scale — p=0.5177

Primary: Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) — 180 Participants

Primary: Unified Parkinson Disease Rating Scale (UPDRS). — 12; 12; 10; 10 units on a scale

Primary: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 — -4; -5.9 Score on scale — p=0.0103

Primary: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) — 17 Participants

Primary: TST — 5.7; 6.0 hours

Primary: The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. — 7; 0 Participants

Primary: Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase — 12.12; 12.29; -5.52; -6.55 Units on a scale — p=0.802

Primary: Change From Baseline to Endpoint of 12 Weeks in the 3-day Average of Awake Time Per Day Spent in the "Off" State — -0.4; -1.3; -1.6; -1.7 hours/day — p=0.753

Primary: Change in Free-water Accumulation in the Substantia Nigra — 0.0009; 0.0041 arbitrary units (A.U.s)

Primary: Most Commonly Reported Past Barrier to Mental Health Services: "Anyone in my Situation Would be Struggling" — 74.8 percentage of total respondents

Primary: Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score — 19.2; 8.1 score on a scale — p=<0.0001

Primary: Longitudinal Change of Brain Network Activity — 0.41; 0.61; 2.21; 3.61 Z-score in PDRP — p=0.84

Primary: Hamilton Depression Rating Scale: Baseline — 20.93; 19.38 units on a scale

Primary: Change in Dopamine Transporter Imaging — 4.6; -15.9 % change in arbitrary intensity units

Primary: Change From Baseline in Mean "Off" Time — -0.9; -0.9; -0.8; -0.8 Hours/day — p=0.8700

Primary: Hamilton Depression Scale — 10.84; 12.45; 15.81 units on a scale

Primary: Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) — 3.92; 3.48 scores on the CGIC

Primary: L-DOPA Insensitivity — 5 Participants — p=0.00468

Primary: Hamilton Depression Rating Scale — 16.46; 21.37; 16.35; 20.70 score on a scale

Primary: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) — 2; 2 Points on a scale

Primary: Time From Randomization to Relapse in the Double-blind (DB) Period — NA; NA days — p=0.0023

Primary: Change in Dementia Rating Scale (DRS) Memory Subscore — 1.6; -1.4 units on a scale

Primary: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks — 4.42; 5.13; 6.25 units on a scale

Primary: Change in Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score — 3.2; 2.5 score on a scale — p=0.53