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. Adult patients, between 18 and 55 years of age

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

3. Has predominant negative symptoms according to predefined study criteria

4. 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

Exclusion Criteria:

1. Patient has a psychiatric disorder other than schizophrenia

2. 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

3. 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

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

5. Patient has a family or personal history or symptoms of long QT syndrome

6. 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).


Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

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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