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

Schizophrenia Clinical Trial

Official title:

A Study to 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187769
• Other study ID #: ALKS 3831-A307
• Status: Completed
• Phase: Phase 3
• Start date: June 8, 2017
• Est. completion date: January 3, 2022

Study information

• Verified date: December 2022
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: January 3, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar I Disorder
• Body Weight
• Disease
• Psychotic Disorders
• Schizophrenia
• Schizophreniform Disorders

Intervention

Drug:
• ALKS 3831
Olanzapine + samidorphan, daily oral dosing
• Olanzapine
Daily oral dosing

Locations

Country	Name	City	State
Austria	Alkermes Investigational Site	Vienna
Germany	Alkermes Investigational Site	Muenchen
Ireland	Alkermes Investigational Site	Galway
Israel	Alkermes Investigational Site	Jerusalem
Israel	Alkermes Investigational Site	Tel HaShomer
Italy	Alkermes Investigational Site	Brescia
Italy	Alkermes Investigational Site	Naples
Italy	Alkermes Investigational Site	Torino
Korea, Republic of	Alkermes Investigational Site	Busan
Korea, Republic of	Alkermes Investigational Site	Daegu
Korea, Republic of	Alkermes Investigational Site	Naju
Korea, Republic of	Alkermes Investigational Site	Seoul
Poland	Alkermes Investigational Site	Poznan
Russian Federation	Alkermes Investigational Site	Arkhangel'sk
Russian Federation	Alkermes Investigational Site	Moscow
Russian Federation	Alkermes Investigational Site	Roshchino
Russian Federation	Alkermes Investigational Site	Rostov-on-Don
Russian Federation	Alkermes Investigational Site	Saint Petersburg
Russian Federation	Alkermes Investigational Site	Samara
Russian Federation	Alkermes Investigational Site	Saratov
Russian Federation	Alkermes Investigational Site	Tonnel'nyy
Spain	Alkermes Investigational Site	Oviedo
Ukraine	Alkermes Investigational Site	Kharkiv
Ukraine	Alkermes Investigational Site	Kyiv
Ukraine	Alkermes Investigational Site	Lviv
Ukraine	Alkermes Investigational Site	Poltava
Ukraine	Alkermes Investigational Site	Smila
Ukraine	Alkermes Investigational Site	Stepanovka
United Kingdom	Alkermes Investigational Site	Guildford
United Kingdom	Alkermes Investigational Site	Headington
United Kingdom	Alkermes Investigational Site	London
United Kingdom	Alkermes Investigational Site	Maidstone
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Augusta	Georgia
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	DeSoto	Texas
United States	Alkermes Investigational Site	Eugene	Oregon
United States	Alkermes Investigational Site	Fort Worth	Texas
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Jacksonville	Florida
United States	Alkermes Investigational Site	Kalamazoo	Michigan
United States	Alkermes Investigational Site	Kansas City	Missouri
United States	Alkermes Investigational Site	Las Vegas	Nevada
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	North Miami	Florida
United States	Alkermes Investigational Site	Richardson	Texas
United States	Alkermes Investigational Site	Rogers	Arkansas
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	San Antonio	Texas
United States	Alkermes Investigational Site	San Diego	California
United States	Alkermes Investigational Site	Stanford	California
United States	Alkermes Investigational Site	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Ireland,  Israel,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight at Week 12	The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug	Baseline and 12 weeks
Secondary	Percentage of Subjects With =10% Weight Gain at Week 12	Percentage of weight gain is analyzed based on the subject's assessment status (=10% vs <10%) at Week 12 using a logistic regression model including treatment group, diagnosis (schizophrenia/schizophreniform disorder vs bipolar I disorder), region (US vs non-US), and baseline BMI (<25 vs =25) as factors and baseline weight as covariate.	Baseline and 12 weeks
Secondary	Percentage of Subjects With =7% Weight Gain at Week 12		Baseline and 12 weeks
Secondary	Number of Participants Experiencing of Adverse Events (AEs)		Up to 16 weeks
Secondary	Change From Baseline in Waist Circumference at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12	Clinical Global Impression-Severity (CGI-S) Score is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. It is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."	Baseline and Week 12