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NCT05303064RecruitingPhase 3

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
220 (estimated)
First submitted
22 Mar 2022
Start date
30 Jun 2022
Primary completion date
Sept 2026
Lead sponsor
Alkermes, Inc.
NCT number
NCT05303064

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 220
  • From 30 Jun 2022 to the primary completion date, Sept 2026
  • 43 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
  • Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
  • Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)
  • Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)
  • Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening
  • Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
  • Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening
  • Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening

Other illness

  • Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study

Lab values

  • Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%)

Other

  • Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Subject has a BMI percentile \>98th or \<5th

Who the study is looking for

  • Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
  • Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
  • Subject has reliable family/legal guardian support available for outpatient management
  • Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
  • Subject must not be a danger to self or others (per Investigator judgement)

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaRecruiting
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CórdobaArgentinaRecruiting
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La PlataArgentinaRecruiting
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MendozaArgentinaRecruiting
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CuritibaBrazilRecruiting
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FortalezaBrazilRecruiting
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GoiâniaBrazilRecruiting
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Rio de JaneiroBrazilRecruiting
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São PauloBrazilRecruiting
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BarranquillaColombiaRecruiting
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BelloColombiaRecruiting
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BogotáColombiaActive, not recruiting
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PereiraColombiaRecruiting
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CuliacánMexicoRecruiting
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Estado de MéxicoMexicoRecruiting
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LeónMexicoRecruiting
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MonterreyMexicoRecruiting
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ChicagoUnited StatesRecruiting
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CincinnatiUnited StatesRecruiting
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Colorado SpringsUnited StatesWithdrawn
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DecaturUnited StatesRecruiting
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DenverUnited StatesActive, not recruiting
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DeSotoUnited StatesTerminated
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DothanUnited StatesRecruiting
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EncinoUnited StatesWithdrawn
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EverettUnited StatesRecruiting
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Fort WorthUnited StatesWithdrawn
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HartfordUnited StatesWithdrawn
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IndianapolisUnited StatesRecruiting
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KinstonUnited StatesWithdrawn
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LincolnUnited StatesRecruiting
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Little RockUnited StatesRecruiting
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MiamiUnited StatesWithdrawn
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Miami LakesUnited StatesRecruiting
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New YorkUnited StatesRecruiting
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OmahaUnited StatesWithdrawn
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ParamusUnited StatesWithdrawn
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RichmondUnited StatesRecruiting
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Saint CharlesUnited StatesRecruiting
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StanfordUnited StatesRecruiting
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UplandUnited StatesWithdrawn
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Washington D.C.United StatesRecruiting
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West ChesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.