Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has a body mass index (BMI) of 18.0-35.0 kg/m\^2, inclusive
Has a primary diagnosis of schizophrenia
Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
Appropriate for outpatient treatment
Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
Willing and able to provide government-issued identification
Is in good physical health
Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
Additional criteria may apply
You may not be if
Is currently pregnant or breastfeeding
Initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
Poses a current suicide risk at Visits 1 or 2
Has a history of poor or inadequate response to treatment with olanzapine
Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
Additional criteria may apply
Clareo Health | A Phase 1 Safety Study in Adults With Schizophrenia
