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 Screening 9. Score =20 on the sum of the 7 PANSS Marder negative factor items at Screening and Baseline AND Score =4 on at least 3, or =5 on at least 2, of the 7 PANSS Marder negative factor items 10. Score =22 on the sum of the 8 PANSS Marder positive factor items AND PANSS score where no more than two of the following items have a score of 4 and none of the following items has a score =5 at both Screening and Baseline: • P1 (delusions) • P3 (hallucinatory behavior) • P4 (excitement) • P6 (suspiciousness/persecution) • P7 (hostility) 11. A Clinical Global Impression of Schizophrenia Scale–Severity (CGI-SCH-S) for the negative symptoms of schizophrenia score =4 (moderately ill or worse) at Screening and Baseline 12. 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 13. The antipsychotic with which the subject is being treated must be one of the antipsychotics listed below: • Aripiprazole o Aripiprazole long-acting injectables o Abilify Maintena® • Aristada® • Asenapine • Brexpiprazole • Cariprazine • Lurasidone • Olanzapine • Risperidone • Risperidone long-acting injection • Paliperidone extended release (ER) (=9 mg) • Paliperidone palmitate o Invega Sustenna® (=156 mg) o Invega Trinza® (=546 mg) o Trevicta® (=350 mg) o Xeplion® (=100 mg) 14. If taking an oral antipsychotic, no dose change within 4 weeks prior to Screening or during the Screening Period 15. If taking a long-acting injectable antipsychotic, no dose change within 16 weeks prior to Screening or during the Screening Period 16. If taking an antidepressant medication or an anxiolytic medication, no dose change within 4 weeks of Screening or during the Screening Period (see also Appendix A for restrictions/prohibitions during the study) 17. Must be medically stable and has been medically stable for at least 12 weeks prior to Screening, in the opinion of the Investigator 18. If the subject is female, sh
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. Score =2 for two or more movements or a score of 3 or 4 for any single movement on the Abnormal Involuntary Movement scale (AIMS) 3. Total score =2 on the Barnes Akathisia Rating Scale (BARS) 4. Total score =5 on the Simpson-Angus Extrapyramidal Side Effects Scale (SAS) 5. Calgary Depression Scale for Schizophrenia (CDSS) score =9 at both Screening and Baseline 6. Is at a significant risk of suicide (e.g., answers “Yes” to suicidal ideation question 4 or 5 [current or over last 6 months] or answers “Yes” to suicidal behavior questions on the C-SSRS [over last 6 months]), in the opinion of the Investigator 7. Has a significant risk of violent behavior in the opinion of the Investigator 8. Has met DSM-5 criteria for substance use disorders within the last 6 months prior to randomization (other than caffeine and/or nicotine) 9. A urine toxicity (drug) screen result at Screening or Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana • Subjects with a result indicating the presence of marijuana are permitted, if allowed by local regulations, if they agree to abstain from marijuana use during the study and the Medical Monitor approves the subject’s participation 10. Subject was treated with two or more antipsychotics, for any indication, within 8 weeks prior to Screening 11. Laboratory testing confirms the absence of the main antipsychotic 12. 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 13. 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 14. Has an ECG result at Screening or Baseline that meets one of the following exclusionary conditions: • If QRS interval 7% at Screening 19. Has a clinically significant thyroid function test result at Screening 20. 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 21. Known to be positive for hepatitis C virus (HCV) or human immunod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of pimavanserin compared with placebo in the adjunctive treatment of the negative symptoms of schizophrenia;Secondary Objective: • To evaluate the effect of adjunctive pimavanserin compared with adjunctive placebo on global impression of severity of illness, global improvement of symptoms of illness, personal and social performance, and response to treatment in adults experiencing negative symptoms of schizophrenia;Primary end point(s): • Change from Baseline to Week 26 in the Negative Symptom Assessment–16 (NSA 16) total score;Timepoint(s) of evaluation of this end point: from Baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoint: • Change from Baseline to Week 26 in the Clinical Global Impression of Schizophrenia Scale–Severity (CGI SCH S) of negative symptoms score Other Secondary Endpoints • Clinical Global Impression of Schizophrenia Scale–Improvement (CGI SCH I) of negative symptoms score at Week 26 • Proportion of CGI-SCH-I of negative symptoms responders (CGI-SCH-I of negative symptoms score of 1 or 2) at Week 26 • Change from Baseline to Week 26 in the Personal and Social Performance (PSP) scale score • Proportion of NSA-16 responders (=20% and =30% reduction in NSA- 16 total score) at Week 26 • Change from Baseline to Week 26 in the Positive and Negative Syndrome Scale (PANSS) total score • Change from Baseline to Week 26 in PANSS negative subscores • Change from Baseline to Week 26 in PANSS Marder factor (negative symptoms) score ;Timepoint(s) of evaluation of this end point: from Baseline to Week 26 | — |
Countries
Bulgaria, Croatia, Czechia, Czech Republic, Hungary, Italy, Lithuania, Poland, Russian Federation, Serbia, Spain, Ukraine
Contacts
Public ContactAlida Barry
ACADIA Pharmaceuticals Inc.
Outcome results
None listed