Study Seeking Patients with Schizophrenia

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Updated on 25 March 2021


Study Seeking Patients with Schizophrenia


A phase III study to evaluate weight gain of ALKS3831 compared to olanzapine in adults with schizophre

Condition Schizophrenia and Schizoaffective Disorders, Psychosis, Mental Disability
Clinical Study IdentifierTX148429
Last Modified on25 March 2021


Yes No Not Sure

Inclusion Criteria

Male or Female 18 to 55 years inclusive
BMI of 18-30 kg/m2
Have DSM 5 Diagnosis of Schizophrenia and symptomatically stable
Subject has maintained a stable body weight (change < 5%) for at least 3 months prior to visit 1 based on self report

Exclusion Criteria

First antipsychotic treatment within the past 12 months or < 1 year has elapsed since the onset of SCPT
History of poor or inadequate response to Olanzapine (Zyprexa)
Positive UDS except THC
Use of any Opioid agonist (codeine, oxycodone, tramadol, morphine) within 14 days prior to Visit 1 and or need to take opioid medication during study
Currently on statin (high cholesterol) medication that has been initiated or dose adjustment in last 3 months
Taking weight loss or hypoglycemic (diabetes medication) agents
Any GI procedures within 1 year prior to Visit 1 or any surgical procedure for weight loss
History of diabetes
Hepatitis B, C, or HIV
Previous clinical trial participation within 3 months of Visit 1
Participation in trial using ALK3831 (Alk-302, Alk 401)
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.

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.

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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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