Clinical trial NCT03187769: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizophreniform Disorders
Bipolar I Disorder
Keywords: Alkermes
ALKS 3831
Olanzapine
Samidorphan
Schizophrenia
Schizophreniform
Bipolar I
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 426
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Percentage of Subjects With ≥10% Weight Gain at Week 12
timeFrame: Baseline and 12 weeks
measure: Percentage of Subjects With ≥7% Weight Gain at Week 12
timeFrame: Baseline and 12 weeks
measure: Number of Participants Experiencing of Adverse Events (AEs)
timeFrame: Up to 16 weeks
measure: Change From Baseline in Waist Circumference at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Stanford
country: United States
facility: Alkermes Investigational Site
state: California
city: Jacksonville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Winfield
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Kalamazoo
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Richardson
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Vienna
country: Austria
facility: Alkermes Investigational Site
city: Muenchen
country: Germany
facility: Alkermes Investigational Site
city: Galway
country: Ireland
facility: Alkermes Investigational Site
city: Jerusalem
country: Israel
facility: Alkermes Investigational Site
city: Tel HaShomer
country: Israel
facility: Alkermes Investigational Site
city: Brescia
country: Italy
facility: Alkermes Investigational Site
city: Naples
country: Italy
facility: Alkermes Investigational Site
city: Torino
country: Italy
facility: Alkermes Investigational Site
city: Busan
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Daegu
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Naju
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Seoul
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Poznań
country: Poland
facility: Alkermes Investigational Site
city: Arkhangel'sk
country: Russian Federation
facility: Alkermes Investigational Site
city: Moscow
country: Russian Federation
facility: Alkermes Investigational Site
city: Roshchino
country: Russian Federation
facility: Alkermes Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Alkermes Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Alkermes Investigational Site
city: Samara
country: Russian Federation
facility: Alkermes Investigational Site
city: Saratov
country: Russian Federation
facility: Alkermes Investigational Site
city: Tonnel'nyy
country: Russian Federation
facility: Alkermes Investigational Site
city: Oviedo
country: Spain
facility: Alkermes Investigational Site
city: Kharkiv
country: Ukraine
facility: Alkermes Investigational Site
city: Kyiv
country: Ukraine
facility: Alkermes Investigational Site
city: Lviv
country: Ukraine
facility: Alkermes Investigational Site
city: Poltava
country: Ukraine
facility: Alkermes Investigational Site
city: Smila
country: Ukraine
facility: Alkermes Investigational Site
city: Stepanovka
country: Ukraine
facility: Alkermes Investigational Site
city: Guildford
country: United Kingdom
facility: Alkermes Investigational Site
city: Headington
country: United Kingdom
facility: Alkermes Investigational Site
city: London
country: United Kingdom
facility: Alkermes Investigational Site
city: Maidstone
country: United Kingdom
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References: