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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05303064




Registration number
NCT05303064
Ethics application status
Date submitted
22/03/2022
Date registered
31/03/2022
Date last updated
29/06/2023

Titles & IDs
Public title
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Scientific title
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)
Secondary ID [1] 0 0
ALKS 3831-A312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Bipolar I Disorder 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OLZ/SAM
Treatment: Drugs - Olanzapine

Experimental: Group 1 OLZ/SAM - Fixed dose combination of olanzapine and samidorphan

Active Comparator: Group 2 Olanzapine - Fixed dose of olanzapine


Treatment: Drugs: OLZ/SAM
OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.

Treatment: Drugs: Olanzapine
The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in body mass index (BMI) Zscore at week 12
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Time to all-cause discontinuation of study drug over 52 weeks
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [3] 0 0
Change from baseline in waist circumference
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Incidence of Adverse Events
Timepoint [7] 0 0
Up to 52 weeks

Eligibility
Key inclusion criteria
- 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)
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject presents with 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

- 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 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 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 a BMI percentile >95th or <5th

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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autonoma Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad Autonoma de Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad de Cordoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Córdoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Mendoza
Country [17] 0 0
Brazil
State/province [17] 0 0
Ceara
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio De Janeiro
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Colombia
State/province [20] 0 0
Barranquilla
Country [21] 0 0
Colombia
State/province [21] 0 0
Bello
Country [22] 0 0
Colombia
State/province [22] 0 0
Bogotá
Country [23] 0 0
Colombia
State/province [23] 0 0
Pereira
Country [24] 0 0
Malaysia
State/province [24] 0 0
Johor Bahru
Country [25] 0 0
Malaysia
State/province [25] 0 0
Kuala Lumpur
Country [26] 0 0
Malaysia
State/province [26] 0 0
Seremban
Country [27] 0 0
Malaysia
State/province [27] 0 0
Sungai Petani
Country [28] 0 0
Mexico
State/province [28] 0 0
Culiacán
Country [29] 0 0
Mexico
State/province [29] 0 0
Durango
Country [30] 0 0
Mexico
State/province [30] 0 0
Estado De México
Country [31] 0 0
Mexico
State/province [31] 0 0
Guadalajara
Country [32] 0 0
Mexico
State/province [32] 0 0
León
Country [33] 0 0
Mexico
State/province [33] 0 0
Monterrey
Country [34] 0 0
Mexico
State/province [34] 0 0
San Luis Potosí

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alkermes, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs
olanzapine
Trial website
https://clinicaltrials.gov/ct2/show/NCT05303064
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
David McDonnell, MD
Address 0 0
Alkermes, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Global Clinical Services
Address 0 0
Country 0 0
Phone 0 0
888-235-8008 (US Only)
Fax 0 0
Email 0 0
clinicaltrials@alkermes.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05303064