Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression

ACADIA Pharmaceuticals Inc.47 enrolled

Overview

The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Treatment of Depression in Adults With Parkinson's Disease (PD)

Interventions

PimavanserinDRUG

Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations 2. Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: 1. rest tremor 2. rigidity 3. bradykinesia and/or akinesia 4. postural and gait abnormalities 3. Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines 4. If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study. 5. Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening 6. If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception Exclusion Criteria: 1. Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer) 2. Had a myocardial infarction within the 6 months prior to Screening 3. Has a known personal or family history or symptoms of long QT syndrome 4. Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor 5. Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder. 6. Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) 7. Is pregnant or breastfeeding 8. Has previously been treated with pimavanserin or is currently taking pimavanserin 9. Has a sensitivity to pimavanserin or its excipients 10. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Locations (21)

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Outcomes

Primary Outcomes

Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score

The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.

Time frame: From baseline to Week 8

Secondary Outcomes

Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6

Time frame: 2, 4, and 6 weeks from baseline

Clinical Global Impression-Improvement (CGI-I)

The CGI-I is a clinician-rated 7-point scale to rate the improvement in the patient's depression at the time of assessment relative baseline. The CGI-I ranges from 1 (very much improved) to 7 (very much worse)

Time frame: At Week 8

Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)

The CGI-S is a clinician-rated 7-point scale to rate the severity of the patient's depression at the time of assessment. The CGI-S ranges from 1 (normal) to 7 (patient is among the most severely ill).

Time frame: From baseline to Week 8

Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score

Data from ClinicalTrials.gov

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