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

Investigator: Philip Harvey

Institutional Protocol #: 20170153

National Clinical Trials Identifier: NCT02970305

Funding Agency/Sponsor: ACADIA PHARMACEUTICALS INC

Division: Psychiatry

Therapeutic Area:

Phase:

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 10/25/2017


Purpose/Abstract:


To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive
placebo in the treatment of the negative symptoms of schizophrenia




Eligibility Criteria:


Inclusion Criteria:

1. Adults patients, aged 18 years and above

2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year

3. Has predominant negative symptoms according to predefined study criteria

4. Has had equal to or less than 10 years of treatment with an antipsychotic

5. The main background antipsychotic with which the subject is being treated must be one
of the antipsychotics listed below:

- Aripiprazole

- Risperidone

- Olanzapine

- Lurasidone

- Cariprazine

- Brexpiprazole

- Asenapine

- Risperidone long-acting injection

- Aripiprazole long-acting injectables:

- Abilify Maintena®

- Aristada®

Exclusion Criteria:

1. Patient has a psychiatric disorder other than schizophrenia

2. Patient has current evidence of a serious and/or unstable 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

3. Patient has had a myocardial infarction in the last six months

4. Patient has a 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).


Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Nicole Brenson, Manager, Business Operations
(305) 243 3487
nbrenson@miami.edu

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