Health Condition 1: F22- Delusional disorders
Conditions
Interventions
Intervention1: Pimavanserin Capsule 34 mg once daily: One capsule should be taken orally once daily, without titration. It can be taken with or without food. Duration of treatment 56 days
Control Inte
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either gender aged greater than or equal to 40 years with a documented clinical diagnosis of idiopathic Parkinsons Disease as per UK PD Society Brain Bank Clinical Diagnostic Criteria of duration greater than or equal to 5.5 years and Hoehn and Yahr stage less than or equal to 3 2 Presence of visual and or auditory hallucinations and or delusions for at least four weeks prior to study screening and the patient must have actively experienced psychotic symptoms each week during last 4 weeks prior to study screening 3 Psychotic symptoms must have developed after Parkinsons disease diagnosis was established 4 Patients must be on a stable dose of anti Parkinsons medication for the last 4 weeks before randomization Day 1 and during the trial 5 Patients who have received stereotaxic surgery for the subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 4 weeks before randomization Day 1 and must remain stable during the trial 6 Patient with psychotic symptoms as mentioned in criteria 3 severe enough to warrant treatment with an antipsychotic agent patient to have a combined score of at least 6 or an individual a score of at least 4 on the neuropsychiatric inventory items A delusions and or B hallucinations at Screening 7 Patient with Scale for the Assessment of Positive Symptoms Hallucinations or Delusions global item H7 or D13 score greater than or equal to 3 and a score greater than 3 on at least one other non global item using the modified 9 item SAPS PD Hallucinations and Delusions domains 8 Patient with a clear sensorium at study entry oriented to time person and place and Mini Mental State Examination MMSE score greater than 21 at Screening 9 Patients taking acetylcholinesterase inhibitors must have the dose of these medications unchanged for at least 21 days before randomization Day 1 and must remain unchanged until the subjects final visit 10 Patients taking anti depressant and anxiolytic medications must have the dose of these medications unchanged for at least 21 days before randomization Day 1 and must remain unchanged until the subjects final visit 11 The patient is willing and able to provide written informed consent 12 Patient has an adult caregiver who is willing and able to accompany the subject to all visits 13 Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing oral intravaginal or transdermal or progesterone only oral injectable or implantable hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system or bilateral tubal occlusion vasectomized partner or total sexual abstinence Note Women with childbearing potential are defined as those who are not 1 surgically sterile bilateral oophorectomy hysterectomy or bilateral tubal ligation or 2 Post menopausal Post menopausal woman will be defined as Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural spontaneous amenorrhea and be greater than 45 years of age 14 Male patie
Exclusion criteria
Exclusion criteria: 1 Patient with history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinsons disease including but not limited to schizophrenia or bipolar disorder 2 Patient with psychotic symptoms hallucinations and delusions which could be better explained clinically as a part of a toxic metabolic or infection induced delirium encephalopathy psychosis due to substance abuse psychosis associated with schizophrenia bipolar disorder or psychotic depression 3 Patients who have received previous ablative stereotaxic surgery i.e. pallidotomy and thalamotomy to treat Parkinsons disease 4 Patient with atypical Parkinsonism or secondary Parkinsonism variants such as tardive or medication induced Parkinsonism 5 Patients with dementia prior to or concomitantly with the diagnosis of Parkinsons disease that may be inconsistent with a PD diagnosis 6 Patient with clinically significant conditions including but not limited to pulmonary central nervous system stroke dementia thyroid uncontrolled hypertension SeSBP greater than or equal to 160 and or SeDBP greater than or equal to 100 mm of Hg and diabetes HbA1c greater than 9 percent at screening renal disease eGFR less than 30 ml per min per 1.73 meter square 7 Patient with cardiac conditions in the last six months including but not limited to myocardial infarction moderate to severe congestive heart failure New York Heart Association NYHA class III or IV congenital prolongation of QT symptomatic bradycardia Bazetts corrected QT QTcB greater than 460 msec if male or 470 msec if female 8 Patient already on antipsychotic medications for PDP 9 Patient who are taking any prior medication as mentioned in the Section 8.1 and are unable to follow a washout period of 21 days before randomization Patients taking medications that can cause QT prolongation requiring washout period 5 times of half life of more than 21 days e.g. amiodarone are not eligible for the study as per Investigators discretion 10 Patient with hypokalemia or hypomagnesemia 11 Patient with surgical or medical condition that in the judgment of the Investigator or Sponsor could interfere with absorption distribution metabolism or excretion of the study drug 12 Patient with any surgery planned during the study period from screening to end of the study 13 Patient with history of Human immunodeficiency virus and or Hepatitis B and or Hepatitis C 14 Patient with history of alcohol and or any other drug abuse as per The Diagnostic and Statistical Manual of Mental Disorders 5 criteria 15 Pregnant or lactating woman 16 Patient with history of participation in another clinical trial in the past 30 days of screening or planning to participate during the study 17 Any contraindication to quetiapine therapy 18 Failure to tolerate quetiapine or pimavanserin previously 19 Patient having hypersensitivity to the study drug or to drugs of similar chemical classes or to any of its excipients 20 Investigator study personnel Sponsor representatives and their first degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in antipsychotic efficacy assessed using SAPS-PD 9-item sum score from baselineTimepoint: 1. Days 1 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1. Change in antipsychotic efficacy assessed using SAPS-PD 9-item sum score from baseline 2. Change in SAPS-H and D, SAPS-H and SAPS-D score from baseline 3. Percentage change in SAPS-H and D, SAPS-H and SAPS-D score from baseline 4. Change in motor symptoms assessed using Unified Parkinsons Disease Rating Scale Part II and Part III from baseline 5. Change in Clinical Global Impression on Improvement and Clinical Global Impression for Severity score from baseline 6. Change in Scales for Outcomes in Parkinsons disease-sleep (night-time sleep and daytime wakefulness) from baseline Safety 1. Treatment emergent adverse event (TEAE)Timepoint: Efficacy 1. Time Frame: Days 1, 14, 28 and 42 2. Time Frame: Days 1, 14, 28, 42 and 56 3. Time Frame: Days 1, 14, 28, 42 and 56 4. Time Frame: Days 1, 14, 28, 42 and 56 5. Time Frame: Days 1, 14, 28, 42 and 56 6. Time Frame: Days 1, 14, 28, 42 and 56 safety 1. Time Frame: Day 1 to Day 56 | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed