Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03482882 |
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Recruitment Status :
Completed
First Posted : March 29, 2018
Results First Posted : August 31, 2020
Last Update Posted : August 31, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment of Depression in Adults With Parkinson's Disease (PD) | Drug: Pimavanserin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 47 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression |
| Actual Study Start Date : | March 9, 2018 |
| Actual Primary Completion Date : | July 9, 2019 |
| Actual Study Completion Date : | July 24, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Drug - pimavanserin |
Drug: Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets) |
- Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score [ Time Frame: From baseline to Week 8 ]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.
- Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6 [ Time Frame: 2, 4, and 6 weeks from baseline ]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.
- Clinical Global Impression-Improvement (CGI-I) [ Time Frame: At Week 8 ]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)
- Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S) [ Time Frame: From baseline to Week 8 ]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).
- Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score [ Time Frame: From baseline to Week 8 ]The SCOPA-NS subscale addresses problems in nighttime sleep and consists of 5 items (sleep initiation, sleep fragmentation, sleep efficiency, sleep duration, early wakening). Each item has 4 response options (ranging from 0=not at all to 3=a lot). The SCOPA-NS score ranges from 0 to 15, with a higher score indicating more severe nighttime sleep problems.
- Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score [ Time Frame: From baseline to Week 8 ]The SCOPA-DS subscale addresses problems in daytime sleepiness and consists of 6 items (falling asleep unexpectedly, falling asleep peacefully, falling asleep watching TV/reading, falling asleep while talking to someone, having difficulty staying awake, whether falling asleep in the daytime is considered a Problem). Each item has 4 response options (from 0=never to 3=often). The SCOPA-DS subscale score ranges from 0 to 18, with a higher score indicating more severe DS problems.
- The Number (or Percentage) of Responders [ Time Frame: From baseline to Week 8 ]
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.
Response was defined as ≥50% reduction from baseline in HAMD-17 total score. Patients without Week-8 score were counted as nonresponders.
- Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: From baseline to Week 8 ]
The EQ-5D-5L is a standardized measure of health status. The questionnaire consists of 2 components: the EQ-5D-5L descriptive system and the EQ-5D-5L Visual Analogue scale (EQ-5D-5L VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (from 1=no problem to 5=extreme Problems). The digits for the 5 dimensions are combined into a 5-digit code that describes the patient's health state, which is then converted into a single summary index value. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
The EQ-5D-5L VAS records the patient's health on a vertical visual analogue scale, ranging from 100 (=the best health you can imagine) to 0 (=the worst health you can imagine).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
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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:
- rest tremor
- rigidity
- bradykinesia and/or akinesia
- postural and gait abnormalities
- Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
- 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.
- Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
- If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception
Exclusion Criteria:
- Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
- Had a myocardial infarction within the 6 months prior to Screening
- Has a known personal or family history or symptoms of long QT syndrome
- Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
- Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
- Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
- Is pregnant or breastfeeding
- Has previously been treated with pimavanserin or is currently taking pimavanserin
- Has a sensitivity to pimavanserin or its excipients
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482882
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Documents provided by ACADIA Pharmaceuticals Inc.:
| Responsible Party: | ACADIA Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT03482882 |
| Other Study ID Numbers: |
ACP-103-048 |
| First Posted: | March 29, 2018 Key Record Dates |
| Results First Posted: | August 31, 2020 |
| Last Update Posted: | August 31, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Parkinson Disease Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |
Pimavanserin Antiparkinson Agents Anti-Dyskinesia Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |