SchizophreniaPhase 3NCT02634346

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

A Phase 3 study testing ALK3831 and Olanzapine in people with Schizophrenia, run by Alkermes, Inc. at 31 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Schizophrenia
What is being tested?: ALK3831 and Olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 403 participants
Where: 31 sitesin 4 countries
Study dates: Dec 2015to 7 Jun 2017
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
Meets criteria for the diagnosis of schizophrenia
Resides in a stable living situation when not hospitalized
Is willing and able to provide government-issued identification
Additional criteria may apply

Who cannot join

Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
Subject poses a current suicide risk
Subject has a history of treatment resistance
Subject has a history of poor or inadequate response to treatment with olanzapine
Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening

Show all 9Show fewer

Subject has a diagnosis of moderate or severe alcohol or drug use disorder
Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
Additional criteria may apply

Trial locations and contacts

31 sites in 4 countries.

Country

City, postcode or hospital

31 sites in 4 countries

United States16 sites

Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Lemon Grove, California, 91945
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Long Beach, California, 90822
Alkermes Investigational Site
Marlton, New Jersey, 08053
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
San Diego, California, 92103
Alkermes Investigational Site
Springdale, Arkansas, 72764
Alkermes Investigational Site
St Louis, Missouri, 63141
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016

Other trials in United States

Bulgaria7 sites

Alkermes Investigational Site
Burgas
Alkermes Investigational Site
Kazanlak
Alkermes Investigational Site
Lovech
Alkermes Investigational Site
Novi Iskar
Alkermes Investigational Site
Plovdiv
Alkermes Investigational Site
Veliko Tarnovo
Alkermes Investigational Site
Vratsa

Other trials in Bulgaria

Ukraine5 sites

Alkermes Investigational Site
Cherkasy
Alkermes Investigational Site
Kherson
Alkermes Investigational Site
Kiev
Alkermes Investigational Site
Lviv
Alkermes Investigational Site
Vinnytsia

Other trials in Ukraine

Serbia3 sites

Alkermes Investigational Site
Belgrade
Alkermes Investigational Site
Kragujevac
Alkermes Investigational Site
Novi Kneževac

Other trials in Serbia

About this study

Official title: A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

Conditions: Schizophrenia
Being tested: ALK3831, Olanzapine, Placebo
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Acute Exacerbation of Schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALK3831Drug
Daily dosing
OlanzapineDrug
Daily dosing
PlaceboDrug
Daily dosing

Study groups in NCT02634346
Study group	Role	What they receive
ALKS 3831	Experimental	Administered as a coated bilayer tablet Receives: Drug: ALK3831
Olanzapine	Active comparator	Administered as a coated bilayer tablet Receives: Drug: Olanzapine
Placebo	Placebo comparator	Administered as a coated bilayer tablet Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
Measured: 4 weeks

Secondary outcomes (2)

Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "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". Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4.
Measured: 4 weeks
Incidence of Adverse Events
Measured: Approximately 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 20157 Jun 2017

First posted18 Dec 2015 (estimated)
Study startDec 2015
Primary completion25 May 2017
Study completion7 Jun 2017

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 (2)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: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02634346
Sponsor's protocol ID: ALKS-3831-A305
Status last verified: May 2018
First submitted: 16 Dec 2015
Last updated: 27 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

McIntyre RS, Matthews DM, Arevalo C, McDonnell D, Correll CU. The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia. J Clin Psychiatry. 2026 Mar 9;87(2):25m16170. doi: 10.4088/JCP.25m16170.
PubMed 41944743
Potkin SG, Kunovac J, Silverman BL, Simmons A, Jiang Y, DiPetrillo L, McDonnell D. Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study. J Clin Psychiatry. 2020 Mar 3;81(2):19m12769. doi: 10.4088/JCP.19m12769.
PubMed 32141723

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
ClinicalTrials.gov ID: NCT02634346
Acronym / sponsor ID: ALKS-3831-A305
Conditions: Schizophrenia
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Acute Exacerbation of Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2015 (actual)
Primary completion: 25 May 2017 (actual)
Study completion: 7 Jun 2017 (actual)
First posted: 18 Dec 2015 (estimated)
Results: Posted 27 Jun 2018

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 efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ALKS 3831	Experimental	Drug: ALK3831Administered as a coated bilayer tablet
Olanzapine	Active comparator	Drug: OlanzapineAdministered as a coated bilayer tablet
Placebo	Placebo comparator	Drug: PlaceboAdministered as a coated bilayer tablet

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
Meets criteria for the diagnosis of schizophrenia
Resides in a stable living situation when not hospitalized
Is willing and able to provide government-issued identification
Additional criteria may apply

Key exclusion criteria (9 listed)

Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
Subject poses a current suicide risk
Subject has a history of treatment resistance
Subject has a history of poor or inadequate response to treatment with olanzapine

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
ALK3831Daily dosing	Drug	ALKS 3831
OlanzapineDaily dosing	Drug	Olanzapine
PlaceboDaily dosing	Drug	Placebo

Primary outcome

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Time frame: 4 weeks
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.

2 secondary outcomes

Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
Time frame: 4 weeks
Incidence of Adverse Events
Time frame: Approximately 4 weeks

Results and safety

Results posted to the registry on 27 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALKS 3831	134	122
Olanzapine	133	119
Placebo	134	111

Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

Time frame: 4 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	ALKS 3831 n = 132	Olanzapine n = 132	Placebo n = 133
Value	-23.9 (1.28)	-22.8 (1.29)	-17.5 (1.32)

ALKS 3831 vs Placebo: Least square mean difference: -6.4 (95% CI -10.0 to -2.8), p <0.001, Mixed Models Analysis
Olanzapine vs Placebo: Least square mean difference: -5.3 (95% CI -8.9 to -1.7), p = 0.004, Mixed Models Analysis

Population analysed: Subjects that received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (TEAEs) are presented for the double-blind treatment period (4 weeks).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALKS 3831	1 of 134 (0.7%)	50 of 134 (37.3%)	0 of 134
Olanzapine	1 of 133 (0.8%)	45 of 133 (33.8%)	1 of 133
Placebo	0 of 134 (0%)	24 of 134 (17.9%)	0 of 134

Limitations and caveats (from the sponsor): The dose of olanzapine was not fixed and could be titrated during the first 2 weeks of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41944743McIntyre RS, Matthews DM, Arevalo C, McDonnell D, Correll CU. The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia. J Clin Psychiatry. 2026 Mar 9;87(2):25m16170. doi: 10.4088/JCP.25m16170.
Derived from this study: PubMed 32141723Potkin SG, Kunovac J, Silverman BL, Simmons A, Jiang Y, DiPetrillo L, McDonnell D. Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study. J Clin Psychiatry. 2020 Mar 3;81(2):19m12769. doi: 10.4088/JCP.19m12769.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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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.

David McDonnell, MD study director

Alkermes, Inc.

31 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALK3831 and Olanzapine in people with Schizophrenia, run by Alkermes, Inc. at 31 sites in 4 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 5 inclusion and 9 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Bulgaria, Ukraine, Serbia. 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. Some participants in this study may receive a placebo. 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 27 Jun 2018). 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?

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (time frame: 4 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 NCT02634346, which also lists 2 linked publications.

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 27 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.