Study Seeking Patients with Schizophrenia

  • STATUS
    Recruiting
  • sponsor
    Acadia
Updated on 25 March 2021

Summary

Study Seeking Patients with Schizophrenia

Description

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ADJUNCTIVE PIMAVANSERIN FOR THE TREATMENT OF SCHIZOPHRENIA

Details
Condition Schizophrenia and Schizoaffective Disorders, Psychosis
Clinical Study IdentifierTX148415
SponsorAcadia
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

> 18 years old
Diagnosis of schizophrenia
Must have caregiver identified for support and input throughout duration of trial
Must have diagnosis > 1 year
Must be predominantly negative symptoms and mild or less positive symptoms
Cannot have had antipsychotic treatment for greater than 10 years
Must be on one of the following background antipsychotics
Aripiprazole
Aripiprazole long acting injectables
Abilify Maintena
Aristada
Asenapine
Brexpiprazole
Cariprazine
Lurasidone
Olanzapine
Risperidone
Risperidone long acting injection
Must be on medication for 8 weeks with no recent dose changes
Must be moderately ill and score moderate or higher on Delusions, Hallucinations, and Suspiciousness
Medically stable
BMI 19-34

Exclusion Criteria

Psychiatric disorder other than schizophrenia
Currently moderately or higher depressive symptoms
Currently at risk of suicide or danger to self or others
Currently taking 3 or more antidepressants
Substance use disorders in last 6 months
Any positive UDS (including marijuana)
Treatment with 2 or more antipsychotics
History of diabetes
Hep C, HIV
Has participated in greater than 2 clinical trials in the last 2 years
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.

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

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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.

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

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