Adjunctive Treatment of Major Depressive DisorderPhase 3NCT04000009
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
A Phase 3 study testing Pimavanserin in people with Adjunctive Treatment of Major Depressive Disorder, run by ACADIA Pharmaceuticals Inc. at 71 sites in 9 countries.
Trial summary
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adjunctive Treatment of Major Depressive Disorder
- 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
- 235 participants
- Where
- 71 sitesin 9 countries
- Study dates
- 6 Jun 2019to 22 Feb 2021
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
- May benefit from longer term therapy with open-label pimavanserin treatment
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception
Who cannot join
- Is determined to be inappropriate for the study
- Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
- Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Trial locations and contacts
71 sites in 9 countries.
71 sites in 9 countries
United States33 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Synexus Clinical Research
Atlanta, Georgia, 30328
Integrative Clinical Trials
Brooklyn, New York, 11229
Social Psychiatry Research Institute (SPRI)
Brooklyn, New York, 11235
Great Lakes Clinical Trials
Chicago, Illinois, 60640
MCB Clinical Research centers, LLC
Colorado Springs, Colorado, 80910
Future Search Trials of Dallas
Dallas, Texas, 75231
CNS Network
Garden Grove, California, 90806
Charak Clinical Research Center
Garfield Heights, Ohio, 44125
Behavioral Research Specialists
Glendale, California, 91206
Baylor College of Medicine
Houston, Texas, 77030
Irvine Clinical Research
Irvine, California, 92614
Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville
Jacksonville, Florida, 32256
Synergy San Diego
Lemon Grove, California, 91945
Capstone Clinical Research
Libertyville, Illinois, 60048
Meridien Research
Maitland, Florida, 32751
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, 38119
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
Florida Research Center, Inc.
Miami, Florida, 33174
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 26464
Department of Psychiatry, Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Medical Research Network, LLC
New York, New York, 10128
Pacific Research Partners, LLC
Oakland, California, 94607
NRC Research Institute
Orange, California, 92868
CNS Health Care (Orlando)
Orlando, Florida, 32801
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Collective Medical Research, LLC
Prairie Village, Kansas, 66208
Finger Lakes Clinical Research
Rochester, New York, 14618
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Adams Clinical
Watertown, Massachusetts, 02472
IPC Research
Waukesha, Wisconsin, 53188
Grayline Research Center
Wichita Falls, Texas, 76309
Russia8 sites
Mental Health Research Center, Department #6
Moscow, 115522
St. Nicholas the Wonder Worker Psychiatric Hospital
Saint Petersburg, 190121
Psychoneurological Dispensary # 5
Saint Petersburg, 195176
City Narcology Hospital
Saint Petersburg, 199004
Samara Psychiatric Hospital
Samara, 443016
Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky
Saratov, 410028
Regional Clinical Psychiatric Hospital of St. Sofia
Saratov, 410060
LION-MED
Voronezh, 394052
Serbia7 sites
Clinical Center of Serbia, Clinic for psychiatry
Belgrade, 11000
Clinical Hospital Center Dr Dragisa Misovic
Belgrade, 11000
Clinical Centre Nis, Clinic for Psychiatry
Gornja Toponica, 18202
Special hospital for psychiatric diseases "Kovin
Kovin, 26220
Clinical Center Kragujevac , Clinic for Psychiatry
Kragujevac, 34000
Clinical Center Kragujevac
Kragujevac, 34000
Centre for Mental Health Protecton, Clinical Center Nis
Niš, 18000
Ukraine6 sites
Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov
Dnipro, 49005
Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"
Kharkiv, 61091
Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"
Kyiv, 01030
Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region,
Stepanovka, 73488
Ternopil Regional Communal Clinical Psychoneurological Hospital, psychiatric department # 2 (men), psychiatric department # 6 (women), Ternopil State Medical University n.a. I.Y. Gorbachevskyy, Chair of Psychiatry, Narcology and Medical Psychology
Ternopil, 46027
Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic
Vinnytsia, 21005
Finland5 sites
ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)
Helsinki, 00100
Savon Psykiatripalvelu Oy
Kuopio, 70110
Oulu Mentalcare Oy
Oulu, 90100
Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori
Pori, 28130
Psykiatri- ja psykologikeskus Mentoria
Tampere, 33200
Poland5 sites
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
Bełchatów, 97-400
Przychodnia Śródmieście Sp. Z o.o.
Bydgoszcz, 85-080
Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała
Gdansk, 80-438
Nzop Mentis
Leszno, 64-100
Zachodniopomorski Instytut Psychoterapii
Szczecin, 70-480
Slovakia3 sites
EPAMED s r.o.
Košice, 04017
Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie
Liptovský Mikuláš, 03123
Centrum Zdravia R.B.K., s.r.o.
Svidník, 50474
United Kingdom3 sites
MAC Clinical Research- Blackpool
Blackpool, FY2 0JH
MAC Clinical Research Ltd.-Liverpool
Liverpool, L34 1BH
MAC Clinical Research- Manchester
Manchester, M13 9NQ
South Africa1 site
Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center
Durbanville, 7550
About this study
Official title: A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.
- 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 (provided as 2×17 mg tablets) administered orally as a single dose once daily
| Study group | Role | What they receive |
|---|---|---|
| Drug - pimavanserin | Experimental | Pimavanserin 34 mg tablets Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events (TEAEs)
Number of patients with treatment emergent AEs
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start6 Jun 2019
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Why it stopped: The study was terminated for business reasons and not due to safety concerns.
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.
- Other trials for Adjunctive Treatment of Major Depressive DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 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
- NCT04000009
- Sponsor's protocol ID
- ACP-103-055
- Other IDs
- 2018-003252-20, 2018
- Status last verified
- Mar 2022
- First submitted
- 25 Jun 2019
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT04000009
- Acronym / sponsor ID
- ACP-103-055
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated for business reasons and not due to safety concerns.
- Enrolment
- 235 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.
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: PimavanserinPimavanserin 34 mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
- May benefit from longer term therapy with open-label pimavanserin treatment
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception
Key exclusion criteria (3 listed)
- Is determined to be inappropriate for the study
- Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
- Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
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 (provided as 2×17 mg tablets) administered orally as a single dose once daily | Drug | Drug - pimavanserin |
Primary outcome
Treatment-emergent Adverse Events (TEAEs)
Time frame: 52 weeks
Number of patients with treatment emergent AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
71 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimavanserin in people with Adjunctive Treatment of Major Depressive Disorder, run by ACADIA Pharmaceuticals Inc. at 71 sites in 9 countries.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Russia, Serbia, Ukraine, Finland and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Apr 2022). 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?
Treatment-emergent Adverse Events (TEAEs) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.