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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03187769

Collaborator

(none)

428

Enrollment

Locations

Arms

54.9

Actual Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophreniform Disorders Bipolar I Disorder	Drug: ALKS 3831 Drug: Olanzapine	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

428 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 8, 2017

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Jan 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALKS 3831 Coated bilayer tablet	Drug: ALKS 3831 Olanzapine + samidorphan, daily oral dosing
Active Comparator: Olanzapine Coated bilayer tablet	Drug: Olanzapine Daily oral dosing

Arm

Intervention/Treatment

Experimental: ALKS 3831

Coated bilayer tablet

Drug: ALKS 3831

Olanzapine + samidorphan, daily oral dosing

Active Comparator: Olanzapine

Coated bilayer tablet

Drug: Olanzapine

Daily oral dosing

Outcome Measures

Primary Outcome Measures

Percent change from baseline in body weight at Week 12 [12 weeks]

Secondary Outcome Measures

Proportion of subjects with ≥10% weight gain at Week 12 [12 weeks]
Proportion of subjects with ≥7% weight gain at Week 12 [12 weeks]
Safety will be measured by frequency of serious and non-serious adverse events [Up to 16 weeks]
Change from baseline in waist circumference at Week 12 [Baseline and Week 12]
Change from baseline in Clinical Global Impression-Severity (CGI-S) score within the ALKS 3831 Group at Week 12 [Baseline and Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alkermes Investigational Site	Little Rock	Arkansas	United States	72211
2	Alkermes Investigational Site	Rogers	Arkansas	United States	72758
3	Alkermes Investigational Site	Garden Grove	California	United States	92845
4	Alkermes Investigational Site	San Diego	California	United States	92013
5	Alkermes Investigational Site	Stanford	California	United States	94305
6	Alkermes Investigational Site	Jacksonville	Florida	United States	32209
7	Alkermes Investigational Site	North Miami	Florida	United States	33161
8	Alkermes Investigational Site	Atlanta	Georgia	United States	30303
9	Alkermes Investigational Site	Atlanta	Georgia	United States	30331
10	Alkermes Investigational Site	Augusta	Georgia	United States	30912
11	Alkermes Investigational Site	Chicago	Illinois	United States	60611
12	Alkermes Investigational Site	Winfield	Illinois	United States	60190
13	Alkermes Investigational Site	Kalamazoo	Michigan	United States	49001
14	Alkermes Investigational Site	Kansas City	Missouri	United States	64108
15	Alkermes Investigational Site	Saint Louis	Missouri	United States	63110
16	Alkermes Investigational Site	Saint Louis	Missouri	United States	63118
17	Alkermes Investigational Site	Saint Louis	Missouri	United States	63128
18	Alkermes Investigational Site	Las Vegas	Nevada	United States	89102
19	Alkermes Investigational Site	Cincinnati	Ohio	United States	45219
20	Alkermes Investigational Site	Eugene	Oregon	United States	97401
21	Alkermes Investigational Site	DeSoto	Texas	United States	75115
22	Alkermes Investigational Site	Fort Worth	Texas	United States	76104
23	Alkermes Investigational Site	Houston	Texas	United States	77030
24	Alkermes Investigational Site	Richardson	Texas	United States	75080
25	Alkermes Investigational Site	San Antonio	Texas	United States	78201
26	Alkermes Investigational Site	Vienna		Austria
27	Alkermes Investigational Site	Muenchen		Germany
28	Alkermes Investigational Site	Galway		Ireland
29	Alkermes Investigational Site	Jerusalem		Israel
30	Alkermes Investigational Site	Tel HaShomer		Israel
31	Alkermes Investigational Site	Brescia		Italy
32	Alkermes Investigational Site	Naples		Italy
33	Alkermes Investigational Site	Torino		Italy
34	Alkermes Investigational Site	Busan		Korea, Republic of
35	Alkermes Investigational Site	Daegu		Korea, Republic of
36	Alkermes Investigational Site	Naju		Korea, Republic of
37	Alkermes Investigational Site	Seoul		Korea, Republic of
38	Alkermes Investigational Site	Poznań		Poland
39	Alkermes Investigational Site	Arkhangel'sk		Russian Federation
40	Alkermes Investigational Site	Moscow		Russian Federation
41	Alkermes Investigational Site	Roshchino		Russian Federation
42	Alkermes Investigational Site	Rostov-on-Don		Russian Federation
43	Alkermes Investigational Site	Saint Petersburg		Russian Federation
44	Alkermes Investigational Site	Samara		Russian Federation
45	Alkermes Investigational Site	Saratov		Russian Federation
46	Alkermes Investigational Site	Tonnel'nyy		Russian Federation
47	Alkermes Investigational Site	Oviedo		Spain
48	Alkermes Investigational Site	Kharkiv		Ukraine
49	Alkermes Investigational Site	Kyiv		Ukraine
50	Alkermes Investigational Site	Lviv		Ukraine
51	Alkermes Investigational Site	Poltava		Ukraine
52	Alkermes Investigational Site	Smila		Ukraine
53	Alkermes Investigational Site	Stepanovka		Ukraine
54	Alkermes Investigational Site	Guildford		United Kingdom
55	Alkermes Investigational Site	Headington		United Kingdom
56	Alkermes Investigational Site	London		United Kingdom
57	Alkermes Investigational Site	Maidstone		United Kingdom