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
Condition: Schizophrenia; Schizophreniform Disorders; Bipolar I Disorder
MeSH terms: Body Weight; Schizophrenia; Psychotic Disorders
Intervention: ALKS 3831; Olanzapine
Intervention description: Olanzapine + samidorphan, daily oral dosing; Daily oral dosing
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Olanzapine; Samidorphan; Schizophrenia; Schizophreniform; Bipolar I

Summary:

      This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in
      young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in
      their illness
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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