A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia
Inclusion Criteria:
Adult patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year
Has predominant negative symptoms according to predefined study criteria
The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
Aripiprazole
Aripiprazole long-acting injectables:
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine
Exclusion Criteria:
Patient has a psychiatric disorder other than schizophrenia
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
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
Patient has had a myocardial infarction in the last six months
Patient has a family or personal history or symptoms of long QT syndrome
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).
Budapest, Pest County 1036, Hungary
Budapest, Pest County 1083, Hungary