Treatment of Depression in Adults With Parkinson's Disease (PD)Phase 2NCT03482882
Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
A Phase 2 study testing Pimavanserin in people with Treatment of Depression in Adults With Parkinson's Disease (PD), run by ACADIA Pharmaceuticals Inc. at 21 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Treatment of Depression in Adults With Parkinson's Disease (PD)
- What is being tested?
- Pimavanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 21 sitesUnited States
- Study dates
- 9 Mar 2018to 24 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Albany Medical College
Albany, New York, 12208
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806
Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, 33486
David L. Kreitzman, MD, PC
Commack, New York, 11725
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
Associated Neurologists, P.C.
Danbury, Connecticut, 06810
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708
University of Florida
Gainesville, Florida, 32607
Neurology/Neurophysiology
Johnstown, Pennsylvania, 15904
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
SC3 Research-Reseda
Pasadena, California, 91105
SRI Biosciences, Clinical Trials and Strategic Development Services
Plymouth, Michigan, 48170
The Neurology Group
Pomona, California, 91767
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, 33980
SC3 Research-Reseda
Reseda, California, 91335
Inland Northwest Research
Spokane, Washington, 99202
Washington University School of medicine
St Louis, Missouri, 63110
Infinity Clinical Research, LLC
Sunrise, Florida, 33351
Tallahassee Neurological Clinic, P.A.
Tallahassee, Florida, 32308
Bio Behavioral Health
Toms River, New Jersey, 08755
CNS Network
Torrance, California, 90502
About this study
Official title: An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.
- Being tested
- Pimavanserin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
| Study group | Role | What they receive |
|---|---|---|
| Drug - pimavanserin | Experimental | Not described Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 8
Secondary outcomes (7)
Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6
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.
Measured: 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)
Measured: 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).
Measured: From baseline to Week 8
Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score
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.
Measured: From baseline to Week 8
Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score
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.
Measured: From baseline to Week 8
The Number (or Percentage) of Responders
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.
Measured: From baseline to Week 8
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
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).
Measured: From baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start9 Mar 2018
- Primary completion9 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment of Depression in Adults With Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482882
- Sponsor's protocol ID
- ACP-103-048
- Status last verified
- Aug 2020
- First submitted
- 23 Mar 2018
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeKarske D, Alva G, Aldred JL, Coate B, Cantillon M, Jacobi L, Nunez R, Norton JC, Abler V. An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson's Disease and Depression. J Parkinsons Dis. 2020;10(4):1751-1761. doi: 10.3233/JPD-202058.
PubMed 32804101
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
- ClinicalTrials.gov ID
- NCT03482882
- Acronym / sponsor ID
- ACP-103-048
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug - pimavanserin | Experimental | Drug: Pimavanserin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
- 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:
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimavanserinPimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets) | Drug | Drug - pimavanserin |
Primary outcome
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.
7 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)
Time frame: At Week 8
Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)
Time frame: From baseline to Week 8
Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score
Time frame: From baseline to Week 8
Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score
Time frame: From baseline to Week 8
The Number (or Percentage) of Responders
Time frame: From baseline to Week 8
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: From baseline to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32804101DeKarske D, Alva G, Aldred JL, Coate B, Cantillon M, Jacobi L, Nunez R, Norton JC, Abler V. An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson's Disease and Depression. J Parkinsons Dis. 2020;10(4):1751-1761. doi: 10.3233/JPD-202058.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimavanserin in people with Treatment of Depression in Adults With Parkinson's Disease (PD), run by ACADIA Pharmaceuticals Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score (time frame: From baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.