Study Seeking Patients with Schizophrenia

  • sponsor
Updated on 25 March 2021


Study Seeking Patients with Schizophrenia


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

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


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.

You are contacting

Investigator Avatar

Primary Contact


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


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 • 



Reply by • Private

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.

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