SchizophreniaPhase 3NCT03187769
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
A Phase 3 study testing ALKS 3831 and Olanzapine in people with Schizophrenia and Schizophreniform Disorders, run by Alkermes, Inc. at 57 sites in 12 countries.
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 Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
- What is being tested?
- ALKS 3831 and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 57 sitesin 12 countries
- Study dates
- 8 Jun 2017to 3 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
57 sites in 12 countries.
57 sites in 12 countries
United States25 sites
Alkermes Investigational Site
Atlanta, Georgia, 30303
Alkermes Investigational Site
Atlanta, Georgia, 30331
Alkermes Investigational Site
Augusta, Georgia, 30912
Alkermes Investigational Site
Chicago, Illinois, 60611
Alkermes Investigational Site
Cincinnati, Ohio, 45219
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Eugene, Oregon, 97401
Alkermes Investigational Site
Fort Worth, Texas, 76104
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Houston, Texas, 77030
Alkermes Investigational Site
Jacksonville, Florida, 32209
Alkermes Investigational Site
Kalamazoo, Michigan, 49001
Alkermes Investigational Site
Kansas City, Missouri, 64108
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
Richardson, Texas, 75080
Alkermes Investigational Site
Rogers, Arkansas, 72758
Alkermes Investigational Site
San Antonio, Texas, 78201
Alkermes Investigational Site
San Diego, California, 92013
Alkermes Investigational Site
St Louis, Missouri, 63110
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
St Louis, Missouri, 63128
Alkermes Investigational Site
Stanford, California, 94305
Alkermes Investigational Site
Winfield, Illinois, 60190
Russia8 sites
Alkermes Investigational Site
Arkhangelsk
Alkermes Investigational Site
Moscow
Alkermes Investigational Site
Roshchino
Alkermes Investigational Site
Rostov-on-Don
Alkermes Investigational Site
Saint Petersburg
Alkermes Investigational Site
Samara
Alkermes Investigational Site
Saratov
Alkermes Investigational Site
Tonnel'nyy
Ukraine6 sites
Alkermes Investigational Site
Kharkiv
Alkermes Investigational Site
Kyiv
Alkermes Investigational Site
Lviv
Alkermes Investigational Site
Poltava
Alkermes Investigational Site
Smila
Alkermes Investigational Site
Stepanovka
South Korea4 sites
Alkermes Investigational Site
Busan
Alkermes Investigational Site
Daegu
Alkermes Investigational Site
Naju
Alkermes Investigational Site
Seoul
United Kingdom4 sites
Alkermes Investigational Site
Guildford
Alkermes Investigational Site
Headington
Alkermes Investigational Site
London
Alkermes Investigational Site
Maidstone
Italy3 sites
Alkermes Investigational Site
Brescia
Alkermes Investigational Site
Naples
Alkermes Investigational Site
Torino
Israel2 sites
Alkermes Investigational Site
Jerusalem
Alkermes Investigational Site
Tel HaShomer
About this study
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
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
Read the 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.
- Being tested
- ALKS 3831, Olanzapine
- Keywords
- Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 3831Drug
Olanzapine + samidorphan, daily oral dosing
OlanzapineDrug
Daily oral dosing
| Study group | Role | What they receive |
|---|---|---|
| ALKS 3831 | Experimental | Coated bilayer tablet Receives: Drug: ALKS 3831 |
| Olanzapine | Active comparator | Coated bilayer tablet Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 weeks
Secondary outcomes (5)
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.
Measured: Baseline and 12 weeks
Percentage of Subjects With ≥7% Weight Gain at Week 12
Measured: Baseline and 12 weeks
Number of Participants Experiencing of Adverse Events (AEs)
Measured: Up to 16 weeks
Change From Baseline in Waist Circumference at Week 12
Measured: Baseline and Week 12
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."
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start8 Jun 2017
- Primary completion1 Dec 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alkermes Medical Director, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187769
- Sponsor's protocol ID
- ALKS 3831-A307
- Status last verified
- Dec 2022
- First submitted
- 8 Jun 2017
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahn RS, Kane JM, Correll CU, Arevalo C, Simmons A, Graham C, Yagoda S, Hu B, McDonnell D. Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study. J Clin Psychiatry. 2023 Mar 22;84(3):22m14674. doi: 10.4088/JCP.22m14674.
PubMed 36946605
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03187769
- Acronym / sponsor ID
- ALKS 3831-A307
- Keywords
- Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALKS 3831 | Experimental | Drug: ALKS 3831Coated bilayer tablet |
| Olanzapine | Active comparator | Drug: OlanzapineCoated bilayer tablet |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALKS 3831Olanzapine + samidorphan, daily oral dosing | Drug | ALKS 3831 |
| OlanzapineDaily oral dosing | Drug | Olanzapine |
Primary outcome
Percent Change From Baseline in Body Weight at Week 12
Time frame: Baseline and 12 weeks
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
5 secondary outcomes
Percentage of Subjects With ≥10% Weight Gain at Week 12
Time frame: Baseline and 12 weeks
Percentage of Subjects With ≥7% Weight Gain at Week 12
Time frame: Baseline and 12 weeks
Number of Participants Experiencing of Adverse Events (AEs)
Time frame: Up to 16 weeks
Change From Baseline in Waist Circumference at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36946605Kahn RS, Kane JM, Correll CU, Arevalo C, Simmons A, Graham C, Yagoda S, Hu B, McDonnell D. Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study. J Clin Psychiatry. 2023 Mar 22;84(3):22m14674. doi: 10.4088/JCP.22m14674.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alkermes Medical Director study director
Alkermes, Inc.
57 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALKS 3831 and Olanzapine in people with Schizophrenia and Schizophreniform Disorders, run by Alkermes, Inc. at 57 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Russia, Ukraine, South Korea, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight at Week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.