Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Status: | Recruiting |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/28/2019 |
Start Date: | December 2016 |
End Date: | May 2021 |
Contact: | Dragana Bugarski-Kirola, MD |
Email: | dbugarski-kirola@acadia-pharm.com |
Phone: | 609-250-6903 |
A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of
adjunctive treatment in subjects with schizophrenia
adjunctive treatment in subjects with schizophrenia
Inclusion Criteria:
1. Patient is able to understand and provide signed informed consent
2. Has a caregiver or some other identified responsible person (e.g., family member,
social worker, caseworker, or nurse) considered reliable by the Investigator in
providing support to the subject to help ensure compliance with study treatment, study
visits, and protocol procedures and who is also able to provide input helpful for
completing study rating scale
3. Is completing the Week 6 visit in Study ACP-103-034 or -039 or the Week 26 visit in
Study ACP-103-038 while continuing to take his/her assigned dose of blinded study drug
and may, in the Investigator's opinion, benefit from continued adjunctive treatment
with pimavanserin to a antipsychotic
4. If female, must be of non-childbearing potential (defined as either surgically
sterilized or at least 1 year postmenopausal) or must agree to use two clinically
acceptable methods of contraception
5. The main background antipsychotic with which the subject is being treated must
continue be one of the antipsychotics listed below:
- Aripiprazole
- Aripiprazole long-acting injectables:
- Abilify Maintena®
- Aristada®
- Asenapine
- Risperidone
- Risperidone long-acting injection
- Olanzapine
- Lurasidone
- Cariprazine
- Brexpiprazole
- Asenapine
Exclusion Criteria:
1. Patient is judged by the Investigator or the Medical Monitor to be inappropriate for
the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -039)
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. Is taking a medication or drug or other substance that is prohibited according to this
protocol
4. Known family or personal history or symptoms of long QT syndrome
5. 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.
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
45
sites
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Wichita, Kansas 67214
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