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Study identifier: NCT03121586 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Terminated

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Condition: Schizophrenia  ·  Sponsor: ACADIA Pharmaceuticals Inc.

PhasePhase 3
Planned participants995
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where161 locations · 14 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Patient is able to understand and provide signed informed consent 2. Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale 3. Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic 4. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception 5. The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below: * Aripiprazole * Aripiprazole long-acting injectables: * Abilify Maintena® * Aristada® * Asenapine * Risperidone * Risperidone long-acting injection * Olanzapine * Paliperidone extended release (ER) (≤9 mg) * Paliperidone palmitate * Invega Sustenna® (≤156 mg) * Invega Trinza® (≤546 mg) * Trevicta® (≤350 mg) * Xeplion® (≤100 mg) * Lurasidone * Cariprazine * Brexpiprazole * Asenapine Exclusion Criteria: 1. Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064) 2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse 1. Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation 2. Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study 3. Is taking a medication or drug or other substance that is prohibited according to this protocol 4. Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval 5. 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 study. 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).

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (161)

171-Alea Research InstitutePhoenix, Arizona, United States
156-Woodland International Research Group, LLCLittle Rock, Arkansas, United States
111-Woodland Research Northwest, LLCRogers, Arkansas, United States
167-CITrials - BellflowerBellflower, California, United States
105-ProScience Research GroupCulver City, California, United States
123-Synergy San DiegoLemon Grove, California, United States
164-Artemis Institute for Clinical ResearchSan Diego, California, United States
165-CITrialsSanta Ana, California, United States
108-Collaborative Nueroscience Network, LLCTorrance, California, United States
125-Galiz ResearchHialeah, Florida, United States
137-Innovative Clinical Research, Inc.Lauderhill, Florida, United States
146-Premier Clinical Research Institute, Inc.Miami, Florida, United States

+ 149 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

PhoenixLittle RockRogersBellflower

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