Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Adults patients, between 18 and 55 years of age
- A clinical diagnosis of schizophrenia with a minimum duration of 1 year
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
- Has had a partial but inadequate response to antipsychotic treatment
- Has a history of response to antipsychotic treatment other than clozapine
Exclusion Criteria:
- Patient has a psychiatric disorder other than schizophrenia
- Patient has a history of resistance to antipsychotic treatment
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 is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pimavanserin
Placebo
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
Placebo + background antipsychotic, taken as two tablets, once daily by mouth