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ClinicalTrials.gov public records Last synced Oct 19, 2026, 5:09 AM EDT

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Showing 1–24 of 30 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Samidorphan Clear all
Completed Phase 3 Interventional Results available

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02873208
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
266 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
43
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Anaheim, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2021 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

NCT02158546
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
447 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
50
States / cities
Little Rock, Arkansas • Bellflower, California • Beverly Hills, California + 45 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2019 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

NCT02158533
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
High Dose ALKS 5461, Low Dose ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
385 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
42
States / cities
Birmingham, Alabama • Tucson, Arizona • Carson, California + 37 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2019 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional

Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

NCT04987658
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
OLZ/SAM
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 12 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
2
States / cities
Decatur, Georgia • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 22, 2023 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

NCT02508506
View directory record Official record
Conditions
Renal Impairment
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 79 Years
Enrollment
22 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
3
States / cities
Denver, Colorado • Orlando, Florida • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Feb 4, 2016 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

NCT02479308
View directory record Official record
Conditions
Healthy
Interventions
Moxifloxacin, ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
129 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 23, 2015 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional

A Phase 1 Safety Study in Adults With Schizophrenia

NCT02804568
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
3
States / cities
Little Rock, Arkansas • Clementon, New Jersey • Dayton, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 22, 2016 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of ALKS 5461 in Healthy Volunteers

NCT02068105
View directory record Official record
Conditions
Pharmacokinetics
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
104 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Apr 21, 2014 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02634346
View directory record Official record
Conditions
Schizophrenia
Interventions
ALK3831, Olanzapine, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
403 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
16
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Culver City, California + 13 more
Source: ClinicalTrials.gov public record
Updated Jun 27, 2018 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 2 Interventional Results available

A Study of ALKS 3831 in Adults With Schizophrenia

NCT01903837
View directory record Official record
Conditions
Schizophrenia
Interventions
Samidorphan (Low Dose), Samidorphan (Medium Dose), Samidorphan (High Dose), Placebo, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
347 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
50
States / cities
Little Rock, Arkansas • Anaheim, California • Costa Mesa, California + 43 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2021 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

An Insulin Sensitivity Study in Healthy Subjects

NCT02922426
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ALKS 3831, Olanzapine, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 40 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2017
U.S. locations
1
States / cities
Chula Vista, California
Source: ClinicalTrials.gov public record
Updated Aug 22, 2017 · Synced Oct 19, 2026, 5:09 AM EDT
Enrolling by invitation Phase 3 Interventional

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

NCT04987229
View directory record Official record
Conditions
Bipolar I Disorder, Schizophrenia
Interventions
OLZ/SAM
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
15
States / cities
Dothan, Alabama • Little Rock, Arkansas • Stanford, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2026 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Water Consumption Study of ALKS 5461 in Healthy Volunteers

NCT02521857
View directory record Official record
Conditions
Healthy
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 10, 2015 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

NCT02694328
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
561 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
52
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Anaheim, California + 46 more
Source: ClinicalTrials.gov public record
Updated Feb 10, 2020 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 2 Interventional Results available

A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

NCT02161718
View directory record Official record
Conditions
Schizophrenia, Alcohol Use Disorder
Interventions
Samidorphan + olanzapine (ALKS 3831), Placebo + olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
58
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Anaheim, California + 50 more
Source: ClinicalTrials.gov public record
Updated Oct 8, 2021 · Synced Oct 19, 2026, 5:09 AM EDT
Available No phase listed Expanded access

An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)

NCT07744113
View directory record Official record
Conditions
Bipolar 1 Disorder, Schizophrenia Disorder
Interventions
OLZ/SAM
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 17 Years
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Aug 4, 2026 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT05547100
View directory record Official record
Conditions
Focus of Study is on Healthy Lactating Women
Interventions
LYBALVI
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Las Vegas, Nevada
Source: ClinicalTrials.gov public record
Updated Feb 10, 2023 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

NCT03188185
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, ALKS 5461 Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
278 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
30
States / cities
Tucson, Arizona • Little Rock, Arkansas • Los Alamitos, California + 27 more
Source: ClinicalTrials.gov public record
Updated Apr 8, 2021 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users

NCT02218021
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Samidorphan, Placebo, Oxycodone
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Dec 2, 2014 · Synced Oct 19, 2026, 5:09 AM EDT
Recruiting Phase 4 Interventional

Exercise and Olanzapine-samidorphan

NCT06740890
View directory record Official record
Conditions
Schizophenia Disorder, Schizoaffective Disorder, Bipolar Disorder I or II, Bipolar Disorder NOS
Interventions
Olanzapine-samidorphan + exercise
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 13, 2026 · Synced Oct 19, 2026, 5:09 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

National Pregnancy Registry for Psychiatric Medications

NCT01246765
View directory record Official record
Conditions
Pregnant Women, Psychotropic Drugs
Interventions
Not listed
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
5,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2033
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 24, 2025 · Synced Oct 19, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

NCT03201757
View directory record Official record
Conditions
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
16 Years to 70 Years
Enrollment
523 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
49
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Anaheim, California + 40 more
Source: ClinicalTrials.gov public record
Updated Sep 26, 2024 · Synced Oct 19, 2026, 5:09 AM EDT
Terminated Phase 3 Interventional Results available

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

NCT03610048
View directory record Official record
Conditions
Refractory Major Depressive Disorder
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 72 Years
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
29
States / cities
Tucson, Arizona • Little Rock, Arkansas • Los Alamitos, California + 26 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2021 · Synced Oct 19, 2026, 5:09 AM EDT
Recruiting Phase 3 Interventional

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064
View directory record Official record
Conditions
Schizophrenia, Bipolar I Disorder
Interventions
OLZ/SAM, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
220 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
26
States / cities
Dothan, Alabama • Little Rock, Arkansas • Encino, California + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2026 · Synced Oct 19, 2026, 5:09 AM EDT