Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
ACADIA Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, =18 and =55 years of age at the time of Screening 2. Able to understand and provide signed informed consent 3. Able to sign and date a request for medical records and/or subject privacy form if applicable according to local regulations 4. In the Investigator’s opinion, is able to understand the nature of the trial, follow protocol requirements, be willing to comply with study drug administration, and discontinue prohibited concomitant medications 5. 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 scales 6. Able to complete subject-reported outcome measures, can be reliably rated on assessment scales, and is willing to participate in audio recording of assessment scales and in an unrecorded telemedicine interview 7. Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria (confirmed using a customized module of the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-5-CT]) 8. Diagnosis of schizophrenia made =1 year prior to randomization 9. Has been treated with an adequate dose of an antipsychotic within the dose range recommended according to the local Prescribing Information for at least 8 weeks prior to Screening and remaining at the same dose during the Screening Period. The subject may be taking a second antipsychotic at the time of Screening. Note: If the subject is taking two antipsychotics at Screening, the Investigator will: • Determine which antipsychotic is the main antipsychotic • Discontinue the other antipsychotic at least 5 half-lives before randomization • Discontinue the other antipsychotic only if it is clinically appropriate; the other antipsychotic should not be discontinued solely to make the subject eligible for enrollment in the study 10. The main antipsychotic with which the subject is being treated must be one of the antipsychotics listed below: • Aripiprazole • Aripiprazole long-acting injectables: – Abilify Maintena® – Aristada® • Asenapine • Brexpiprazole • Cariprazine • Lurasidone • Olanzapine • Risperidone • Risperidone long-acting injection 11. Has had a partial but inadequate response to the antipsychotic treatment 12. If taking an oral antipsychotic, no dose change within 4 weeks prior to Screening or during the Screening Period 13. If taking a long-acting injectable antipsychotic, no dose change within 16 weeks prior to Screening or during the Screening Period 14. PANSS total score =65 and =110 at Screening and Baseline and there is no change in PANSS total score >30% from Screening to Baseline
Exclusion criteria
Exclusion criteria: 1. Based on the SCID-5-CT, has a current comorbid psychiatric disorder other than schizophrenia (e.g., bipolar disorder, obsessive compulsive disorder, substance abuse) or a disorder that would interfere with the ability to complete study assessments (e.g., intellectual disability) 2. Has a history of resistance to antipsychotic treatment, as defined by either of the following criteria: • Failed to show even minimal response to =2 adequate antipsychotic medications prescribed at adequate doses for adequate length of time; failure to tolerate a medication does not constitute failure to respond • History of treatment with clozapine for refractory psychosis or use of clozapine within the past 12 weeks prior to Screening 3. Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator 4. Has a significant risk of violent behavior in the opinion of the Investigator 5. Has met DSM-5 criteria for substance use disorders within the last 6 months prior to randomization (other than caffeine and/or nicotine) 6. A urine drug screen result at Screening or Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana • Subjects 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 7. Subject was treated with 3 or more antipsychotics, for any indication, within 8 weeks prior to Screening 8. Laboratory testing confirms the absence of the main antipsychotic 9. Is taking a medication or drug or other substance that is prohibited according to this protocol, including medications that prolong the QT interval, strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers. 10. Known family or personal history or symptoms of long QT syndrome 11. Has an ECG result at Screening or Baseline that meets one of the following exclusionary conditions: • If QRS interval 7% at Screening 16. Has a clinically significant thyroid function test result at Screening 17. Has clinically significant laboratory abnormalities that in the judgment of the Investigator or Medical Monitor would jeopardize the safe participation of the subject in the study 18. Known to b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia; Secondary Objective: To evaluate the effect on global impression of severity of illness, global improvement of symptoms of illness, and response to treatment with adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia ;Primary end point(s): Change from Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) total score;Timepoint(s) of evaluation of this end point: from Baseline to Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoint: Change from Baseline to Week 6 in the Clinical Global Impression – Severity scale (CGI-S) score Other secondary endpoints include: • Clinical Global Impression – Improvement (CGI-I) score at Week 6 • Proportion of responders at Week 6 according to each of the following: – PANSS (=20% and =30% reduction in PANSS total score) – CGI-I (CGI-I score of 1 or 2) ;Timepoint(s) of evaluation of this end point: from Baseline to Week 6 | — |
Countries
Argentina, Bulgaria, Chile, Croatia, Germany, Italy, Lithuania, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactDaryl DeKarske
ACADIA Pharmaceuticals Inc.
Outcome results
None listed