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

Description

The purpose of this study is to assess the efficacy of pimavanserin when given adjunctively to a selective serotonin reuptake inhibitor/selective norepinephrine reuptake inhibitor (SSRI/SNRI) for the treatment of depression in adults with Parkinson's disease.

Study Start Date

March, 09 2018

Estimated Completion Date

May 2019

Interventions

  • Drug: Pimavanserin

Study ID

ACADIA Pharmaceuticals Inc. -- ACP-103-048

Status

Recruiting

Trial ID

NCT03482882

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

65

Sponsor

ACADIA Pharmaceuticals Inc.

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. Is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range 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 Screening or 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.

Gender

All

Ages

50 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Associated Neurologists PC - Danbury, Connecticut 16.1 miles None None None
Bio Behavioral Health - Toms River, New Jersey 98.6 miles None None None
Asheville Neurology Specialists PA - Asheville, North Carolina 640.1 miles None None None
Parkinsons Disease and Movement Disorder Center of Boca Raton - Boca Raton, Florida 1,102.6 miles None None None
Parkinsons Disease Treatment Center of SW Florida - Port Charlotte, Florida 1,106.6 miles None None None
Infinity Clinical Research LLC - Sunrise, Florida 1,116.7 miles None None None
Inland Northwest Research - Spokane, Washington 2,196.8 miles None None None
ATP Clinical Research Inc - Costa Mesa, California 2,482.8 miles None None None
The Parkinsons and Movement Disorder Institute - Fountain Valley, California 2,483.5 miles None None None
CNS Network - Torrance, California 2,498.1 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.