Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)
NCT ID: NCT02970305
Last Updated: 2020-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
403 participants
INTERVENTIONAL
2016-11-04
2019-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pimavanserin
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, taken as two tablets, once daily by mouth
Placebo
Placebo, taken as two tablets + background antipsychotic, once daily by mouth
Placebo
Placebo, taken as two tablets, once daily by mouth
Interventions
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Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, taken as two tablets, once daily by mouth
Placebo
Placebo, taken as two tablets, once daily by mouth
Eligibility Criteria
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Inclusion Criteria
2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year
3. Has predominant negative symptoms according to predefined study criteria
4. The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
* Aripiprazole
* Aripiprazole long-acting injectables:
* Abilify Maintena®
* Aristada®
* Risperidone
* Risperidone long-acting injection
* Olanzapine
* Lurasidone
* Cariprazine
* Brexpiprazole
* Asenapine
Exclusion Criteria
2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana
a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
3. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
4. Patient has had a myocardial infarction in the last six months
5. Patient has a family or personal history or symptoms of long QT syndrome
6. Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening
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).
18 Years
55 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Rogers, Arkansas, United States
Bellflower, California, United States
Lemon Grove, California, United States
Norwalk, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Torrance, California, United States
Hialeah, Florida, United States
Lauderhill, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
Wichita, Kansas, United States
Ann Arbor, Michigan, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Oklahoma City, Oklahoma, United States
Downingtown, Pennsylvania, United States
Charleston, South Carolina, United States
Irving, Texas, United States
Richardson, Texas, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Targovishte, , Bulgaria
Tserova Koria, , Bulgaria
Varna, , Bulgaria
Penticton, British Columbia, Canada
Chatham, Ontario, Canada
Montreal, Quebec, Canada
Toronto, , Canada
Hradec Králové, Vekose, Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Říčany, , Czechia
Kalocsa, Bács-Kiskun Megya, Hungary
Budapest, Pest County, Hungary
Budapest, Pest County, Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Pécs, , Hungary
Bialystok, , Poland
Bydgoszcz, , Poland
Lublin, , Poland
Lublin, , Poland
Pruszcz Gdański, , Poland
Roshchino, Leningradskaya Oblast', Russia
Plekhanovo, Lipetsk Oblast, Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Stavropol, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Belgrade, , Serbia
Kovin, , Serbia
Kovin, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Barcelona, , Spain
Madrid, , Spain
Oviedo, , Spain
Valladolid, , Spain
Zamora, , Spain
Dnipro, , Ukraine
Hlevakha, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Oleksandrivka, , Ukraine
Poltava, , Ukraine
Smila, , Ukraine
Vinnytsia, , Ukraine
Countries
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References
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Bugarski-Kirola D, Abbs B, Odetalla R, Liu IY, Darwish M, DeKarske D. Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies. Patient Prefer Adherence. 2024 Jan 19;18:207-216. doi: 10.2147/PPA.S436041. eCollection 2024.
Darwish M, Bugarski-Kirola D, Passarell J, Owen J, Jaworowicz D, DeKarske D, Stankovic S. Pimavanserin Exposure-Response Analyses in Patients With Schizophrenia: Results From the Phase 2 ADVANCE Study. J Clin Psychopharmacol. 2022 Nov-Dec 01;42(6):544-551. doi: 10.1097/JCP.0000000000001611. Epub 2022 Oct 3.
Bugarski-Kirola D, Arango C, Fava M, Nasrallah H, Liu IY, Abbs B, Stankovic S. Pimavanserin for negative symptoms of schizophrenia: results from the ADVANCE phase 2 randomised, placebo-controlled trial in North America and Europe. Lancet Psychiatry. 2022 Jan;9(1):46-58. doi: 10.1016/S2215-0366(21)00386-2. Epub 2021 Nov 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003436-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACP-103-038
Identifier Type: -
Identifier Source: org_study_id