Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

  • STATUS
    Recruiting
  • End date
    Mar 22, 2024
  • participants needed
    500
  • sponsor
    ACADIA Pharmaceuticals Inc.
Updated on 25 February 2022
adjunctive treatment
antipsychotics
brexpiprazole
olanzapine
aripiprazole
lurasidone
risperidone
abilify
asenapine
paliperidone
cariprazine

Summary

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Details
Condition Schizophrenia
Treatment Pimavanserin
Clinical Study IdentifierNCT03121586
SponsorACADIA Pharmaceuticals Inc.
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is able to understand and provide signed informed consent
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
Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 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
If the subject is female, she must not be pregnant or breastfeeding. She must also 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
The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below
Aripiprazole
Aripiprazole long-acting injectables
Abilify Maintena
Aristada
Asenapine
Risperidone
Risperidone long-acting injection
Olanzapine
Paliperidone extended release (ER) (9 mg)
Lurasidone
Cariprazine
Paliperidone palmitate
Brexpiprazole
Invega Sustenna (156 mg)
Asenapine
Invega Trinza (546 mg)
Trevicta (350 mg)
Xeplion (100 mg)

Exclusion Criteria

Is taking a medication or drug or other substance that is prohibited according to this protocol
Patients will be evaluated at screening to ensure that all criteria for study
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 -064)
participation are met. Patients may be excluded from the study based on these
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
assessments (and specifically if it is determined that their baseline health
Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
and psychiatric condition do not meet all pre-specified entry criteria)
Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
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 study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note