Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Alkermes, Inc.
In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.
Age
16–40
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
* Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
Has less than 4 years elapse since the initial onset of active-phase of symptoms
Has a body mass index (BMI) of \<30 kg/m\^2
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
Suitable for outpatient treatment
Additional criteria may apply
You may not be if
Poses a current suicide risk
Has a history of poor or inadequate response to treatment with olanzapine
Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has \> 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) \>2 months prior to Visit 1
Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
Taking any weight loss agents or hypoglycemic agents
Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy
Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
Has started a smoking cessation program within the past 6 months
Has a history of diabetes
Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
Additional criteria may apply
Clareo Health | Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
