SchizophreniaPhase 2NCT01903837

A Study of ALKS 3831 in Adults With Schizophrenia

A Phase 2 study testing Samidorphan (Low Dose), Samidorphan (Medium Dose) and Samidorphan (High Dose) in people with Schizophrenia, run by Alkermes, Inc. at 61 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Schizophrenia
What is being tested?: Samidorphan (Low Dose), Samidorphan (Medium Dose) and Samidorphan (High Dose)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 347 participants
Where: 61 sitesin 3 countries
Study dates: Jun 2013to Mar 2015
Phase: Phase 2
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 18 to 50 years, inclusive
Body mass index (BMI) of 17-30 kg/m2, inclusive
Diagnosis of schizophrenia that is clinically stable

Who cannot join

Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
Current diagnosis of alcohol or drug use disorder, moderate or severe
Clinically significant or unstable medical illness, condition, or disorder
Pregnant or breastfeeding
Significant changes in diet or exercise regimen or plans to join a weight management program during the study
Opioid medications taken within 14 days and/or need to take opioid medication during the study period
History of hypersensitivity to or intolerance of olanzapine
Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year

Trial locations and contacts

61 sites in 3 countries.

Country

City, postcode or hospital

61 sites in 3 countries

United States50 sites

Alkermes Investigational Site
Anaheim, California, 92805
Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Austin, Texas, 78731
Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Bradenton, Florida, 34208
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Charleston, South Carolina, 29407
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Costa Mesa, California, 92626
Alkermes Investigational Site
Creve Coeur, Missouri, 63141
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dallas, Texas, 75231
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Escondido, California, 92025
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Fort Lauderdale, Florida, 33308
Alkermes Investigational Site
Gainesville, Florida, 32607
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Houston, Texas, 77007
Alkermes Investigational Site
Houston, Texas, 77008
Alkermes Investigational Site
Kissimmee, Florida, 34741
Alkermes Investigational Site
Lake Charles, Louisiana, 70629
Alkermes Investigational Site
Leesburg, Florida, 34748
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Marlton, New Jersey, 08053
Alkermes Investigational Site
Mason, Ohio, 45040
Alkermes Investigational Site
Memphis, Tennessee, 38119
Alkermes Investigational Site
National City, California, 91950
Alkermes Investigational Site
Neptune City, New Jersey, 07754
Alkermes Investigational Site
New Britain, Connecticut, 06052
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oakland Park, Florida, 33334
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73103
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73116
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Orlando, Florida, 32810
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19139
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Richland, Washington, 99362
Alkermes Investigational Site
Rockville, Maryland, 20850
Alkermes Investigational Site
Salt Lake City, Utah, 84106
Alkermes Investigational Site
San Diego, California, 92103
Alkermes Investigational Site
Shreveport, Louisiana, 71101
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
Torrance, California, 90502
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016

Other trials in United States

Bulgaria9 sites

Alkermes Investigational Site
Burgas, 8000
Alkermes Investigational Site
Kazanlak, 6100
Alkermes Investigational Site
Lovech, 5500
Alkermes Investigational Site
Novi Iskar, 1280
Alkermes Investigational Site
Pazardzhik, 4400
Alkermes Investigational Site
Sofia, 1606
Alkermes Investigational Site
Tserova Koria, 8260
Alkermes Investigational Site
Varna, 9020
Alkermes Investigational Site
Vratsa, 3000

Other trials in Bulgaria

Czechia2 sites

Alkermes Investigational Site
Brno-mesto
Alkermes Investigational Site
Prague

Other trials in Czechia

About this study

Official title: A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine

Conditions: Schizophrenia
Being tested: Samidorphan (Low Dose), Samidorphan (Medium Dose), Samidorphan (High Dose), Placebo, Olanzapine
Keywords: Schizophrenia, Olanzapine, Samidorphan, Alkermes
Medical subject headings: Schizophrenia

What participants receive

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

Samidorphan (Low Dose)Drug
Also called Low dose samidorphan (ALKS 33)
Tablets taken once daily
Samidorphan (Medium Dose)Drug
Also called Medium dose samidorphan (ALKS 33)
Tablets taken once daily
Samidorphan (High Dose)Drug
Also called High dose samidorphan (ALKS 33)
Tablets taken once daily
PlaceboDrug
Tablets taken once daily
OlanzapineDrug
Tablets taken once daily

Study groups in NCT01903837
Study group	Role	What they receive
Low Dose	Experimental	Olanzapine + low dose samidorphan tablets taken once daily Receives: Drug: Samidorphan (Low Dose); Drug: Olanzapine
Medium Dose	Experimental	Olanzapine + medium dose samidorphan tablets taken once daily Receives: Drug: Samidorphan (Medium Dose); Drug: Olanzapine
High Dose	Experimental	Olanzapine + high dose samidorphan tablets taken once daily Receives: Drug: Samidorphan (High Dose); Drug: Olanzapine
Placebo	Placebo comparator	Olanzapine + placebo tablets taken once daily Receives: Drug: Placebo; Drug: Olanzapine

What is being measured

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

Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
Change from baseline (Day 8) to Day 92 (end of study Part A).
The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
Measured: Baseline (Day 8) to Day 92 (end of study Part A)

Secondary outcomes (4)

Percent Change in Body Weight (Kilogram) From Baseline to Day 92
Percent change from baseline (Day 8) to the end of Part A (Day 92)
Measured: Baseline (Day 8) to Day 92 (end of study Part A)
Absolute Change in Body Weight (kg) From Baseline to Day 92
Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)
Measured: Baseline (Day 8) to Day 92 (end of study Part A)
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
Significant weight gain will include a >=5%, >= 7%, or >=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)
Measured: Baseline (Day 8) to Day 92 (end of study Part A)
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92).
The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.
Measured: Baseline (Day 8) to Day 92 (end of study Part A)

Timeline

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

Jun 2013Mar 2015

First posted19 Jul 2013 (estimated)
Study startJun 2013
Primary completionDec 2014
Study completionMar 2015

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 347 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01903837
Sponsor's protocol ID: ALK3831-302
Status last verified: Sep 2021
First submitted: 5 Jul 2013
Last updated: 6 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Martin WF, Correll CU, Weiden PJ, Jiang Y, Pathak S, DiPetrillo L, Silverman BL, Ehrich EW. Mitigation of Olanzapine-Induced Weight Gain With Samidorphan, an Opioid Antagonist: A Randomized Double-Blind Phase 2 Study in Patients With Schizophrenia. Am J Psychiatry. 2019 Jun 1;176(6):457-467. doi: 10.1176/appi.ajp.2018.18030280. Epub 2019 Mar 8.
PubMed 30845818

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 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
ClinicalTrials.gov ID: NCT01903837
Acronym / sponsor ID: ALK3831-302
Conditions: Schizophrenia
Keywords: Schizophrenia, Olanzapine, Samidorphan, Alkermes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 347 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Dec 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 19 Jul 2013 (estimated)
Results: Posted 8 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Low Dose	Experimental	Drug: Samidorphan (Low Dose), Drug: OlanzapineOlanzapine + low dose samidorphan tablets taken once daily
Medium Dose	Experimental	Drug: Samidorphan (Medium Dose), Drug: OlanzapineOlanzapine + medium dose samidorphan tablets taken once daily
High Dose	Experimental	Drug: Samidorphan (High Dose), Drug: OlanzapineOlanzapine + high dose samidorphan tablets taken once daily
Placebo	Placebo comparator	Drug: Placebo, Drug: OlanzapineOlanzapine + placebo tablets taken once daily

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age 18 to 50 years, inclusive
Body mass index (BMI) of 17-30 kg/m2, inclusive
Diagnosis of schizophrenia that is clinically stable

Key exclusion criteria (8 listed)

Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
Current diagnosis of alcohol or drug use disorder, moderate or severe
Clinically significant or unstable medical illness, condition, or disorder
Pregnant or breastfeeding
Significant changes in diet or exercise regimen or plans to join a weight management program during the study

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
Samidorphan (Low Dose)Also: Low dose samidorphan (ALKS 33)Tablets taken once daily	Drug	Low Dose
Samidorphan (Medium Dose)Also: Medium dose samidorphan (ALKS 33)Tablets taken once daily	Drug	Medium Dose
Samidorphan (High Dose)Also: High dose samidorphan (ALKS 33)Tablets taken once daily	Drug	High Dose
PlaceboTablets taken once daily	Drug	Placebo
OlanzapineTablets taken once daily	Drug	High Dose, Low Dose, Medium Dose, Placebo

Primary outcome

Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
Time frame: Baseline (Day 8) to Day 92 (end of study Part A)
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.

4 secondary outcomes

Percent Change in Body Weight (Kilogram) From Baseline to Day 92
Time frame: Baseline (Day 8) to Day 92 (end of study Part A)
Absolute Change in Body Weight (kg) From Baseline to Day 92
Time frame: Baseline (Day 8) to Day 92 (end of study Part A)
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
Time frame: Baseline (Day 8) to Day 92 (end of study Part A)
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
Time frame: Baseline (Day 8) to Day 92 (end of study Part A)

Results and safety

Results posted to the registry on 8 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olz + Placebo/ Olz+Sam 20mg	75	56
Olz + Sam 5mg / Olz + Sam 5mg	80	52
Olz + Sam 10mg /Olz + Sam 10mg	86	58
Olz + Sam 20mg/ Olz + Sam 20mg	68	55

Primary outcome: Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score

Time frame: Baseline (Day 8) to Day 92 (end of study Part A). Least squares mean (Standard Error). Unit: units on a scale

Measure	Part A FAS 1 - Olz + Placebo n = 74	Part A FAS 1 - Olz + Sam 5mg n = 75	Part A FAS 1- Olz+ Sam 10mg n = 83	Part A FAS 1- Olz+ Sam 20mg n = 68
Value	-2.9 (0.82)	-1.5 (0.85)	-2.7 (0.79)	-2.5 (0.83)

Part A FAS 1 - Olz + Placebo vs Part A FAS 1 - Olz + Sam 5mg vs Part A FAS 1- Olz+ Sam 10mg vs Part A FAS 1- Olz+ Sam 20mg: Least Square Mean Difference: 0.3 (95% CI -2.0 to 2.6), p = 0.3, Least Square Mean Difference

Population analysed: Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A- Olz + Placebo	2 of 75 (2.7%)	33 of 75 (44%)	0 of 75
Part A-Olz + Sam 5mg	3 of 80 (3.8%)	25 of 80 (31.3%)	0 of 80
Part A- Olz + Sam 10mg	4 of 86 (4.7%)	33 of 86 (38.4%)	0 of 86
Part A- Olz + Sam 20mg	4 of 68 (5.9%)	33 of 68 (48.5%)	0 of 68
Part B-Olz +Placebo/ Olz+Sam 20mg	1 of 54 (1.9%)	11 of 54 (20.4%)	0 of 54
Part B- Olz + Sam 5mg / Olz +Sam 5mg	1 of 52 (1.9%)	10 of 52 (19.2%)	0 of 52
Part B- Olz + Sam 10mg/ Olz + Sam 10mg	1 of 57 (1.8%)	11 of 57 (19.3%)	0 of 57
Part B-Olz + Sam 20mg/ Olz + Sam 20mg	0 of 55 (0%)	12 of 55 (21.8%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30845818Martin WF, Correll CU, Weiden PJ, Jiang Y, Pathak S, DiPetrillo L, Silverman BL, Ehrich EW. Mitigation of Olanzapine-Induced Weight Gain With Samidorphan, an Opioid Antagonist: A Randomized Double-Blind Phase 2 Study in Patients With Schizophrenia. Am J Psychiatry. 2019 Jun 1;176(6):457-467. doi: 10.1176/appi.ajp.2018.18030280. Epub 2019 Mar 8.

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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.

Bernard L. Silverman, MD study director

Alkermes, Inc.

61 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Samidorphan (Low Dose), Samidorphan (Medium Dose) and Samidorphan (High Dose) in people with Schizophrenia, run by Alkermes, Inc. at 61 sites in 3 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 3 inclusion and 8 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Bulgaria, Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Sep 2021). 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?

Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score (time frame: Baseline (Day 8) to Day 92 (end of study Part A)). 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 NCT01903837, 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 6 Oct 2021.