Study Seeking Patients with Schizophrenia

  • STATUS
    Recruiting
  • sponsor
    Alkermes
Updated on 25 March 2021

Summary

Study Seeking Patients with Schizophrenia

Description

A Phase 3 study to determine the antipsychotic efficacy and safety of ALKS 3831 in adult subjects with Acute Exacerbation of Schizophrenia.

Details
Condition Schizophrenia and Schizoaffective Disorders
Clinical Study IdentifierTX146924
SponsorAlkermes
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Between the ages of 18 and 70 (inclusive)
BMI between 18-40
Diagnosis of schizophrenia and experiencing an acute exacerbation or relapse (no newly diagnosed subjects, more than a year since initial diagnosis)

Exclusion Criteria

Subject has participated in a clinical study with ALKS 3831 or samidorphan at any time or has participated in any other clinical trial (received study medication) within 6 months before screening
History of diabetes
No use of depot antipsychotic medication in the last 6 months
Any subject presenting with schizoaffective disorder or bipolar I or II disorder, or current untreated or unstable MDD
Subject has a diagnosis of moderate or severe alcohol or drug use disorder currently or 3 months prior to screening. -Subject has a positive UDS for opioids, amphetamine/ methamphetamine, phencyclidine, or cocaine at screening
Any subject reporting suicidal ideations of type 4 or 5 on the C-SSRS with the most recent episode occurring within the past 2 months or yes to any of the 5 items (CSSRS behavior) with an episode occurring within the last year
Subjects with a history of HIV infection or demonstration of HIV antibodies. Positive serology test for hepatitis B surface antigen, hepatitis C antibody
Any subjects who have received clozapine ( verified by the clozapine patient registry)
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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