Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:2/27/2019
Start Date:October 2016
End Date:September 2019
Contact:Ken Smith
Email:ksmith@acadia-pharm.com
Phone:609-250-6908

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia

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


Inclusion Criteria:

1. Adults patients, between 18 and 55 years of age

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

3. 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

4. Has had a partial but inadequate response to antipsychotic treatment

5. Has a history of response to antipsychotic treatment other than clozapine

Exclusion Criteria:

1. Patient has a psychiatric disorder other than schizophrenia

2. Patient has a history of resistance to antipsychotic treatment

3. 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

4. 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

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

6. 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).
We found this trial at
34
sites
Hoffman Estates, Illinois 60194
301
mi
from 43215
Hoffman Estates, IL
Click here to add this to my saved trials
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
1970
mi
from 43215
Bellflower, CA
Click here to add this to my saved trials
428
mi
from 43215
Berlin, NJ
Click here to add this to my saved trials
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
5274
mi
from 43215
Burgas,
Click here to add this to my saved trials
337
mi
from 43215
Catonsville, MD
Click here to add this to my saved trials
491
mi
from 43215
Cedarhurst, NY
Click here to add this to my saved trials
1967
mi
from 43215
Cerritos, CA
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
1981
mi
from 43215
Culver City, CA
Click here to add this to my saved trials
64
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
487
mi
from 43215
Jamaica, NY
Click here to add this to my saved trials
884
mi
from 43215
Lake Charles, LA
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
967
mi
from 43215
Lauderhill, FL
Click here to add this to my saved trials
1944
mi
from 43215
Lemon Grove, CA
Click here to add this to my saved trials
622
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
1967
mi
from 43215
Norwalk, CA
Click here to add this to my saved trials
792
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
900
mi
from 43215
Richardson, TX
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
652
mi
from 43215
Rogers, AR
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
1960
mi
from 43215
Santa Ana, CA
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
1983
mi
from 43215
Torrance, CA
Click here to add this to my saved trials