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

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

NCT02218008
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
407 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
32
States / cities
Birmingham, Alabama • Colton, California • Garden Grove, California + 29 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2019 · Synced Sep 3, 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 7, 2021 · Synced Sep 3, 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 1, 2014 · Synced Sep 3, 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 5, 2021 · Synced Sep 3, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03187769
View directory record Official record
Conditions
Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
Interventions
ALKS 3831, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
16 Years to 40 Years
Enrollment
426 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
25
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Garden Grove, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jan 18, 2023 · Synced Sep 3, 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 22, 2015 · Synced Sep 3, 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 21, 2023 · Synced Sep 3, 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 9, 2023 · Synced Sep 3, 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 3, 2026 · Synced Sep 3, 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 26, 2018 · Synced Sep 3, 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 13, 2026 · Synced Sep 3, 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 13, 2019 · Synced Sep 3, 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 25, 2024 · Synced Sep 3, 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 15, 2021 · Synced Sep 3, 2026, 5:09 AM EDT
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 20, 2021 · Synced Sep 3, 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 23, 2025 · Synced Sep 3, 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 21, 2017 · Synced Sep 3, 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 20, 2014 · Synced Sep 3, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

NCT02545439
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 9, 2015 · Synced Sep 3, 2026, 5:09 AM EDT
Completed Phase 3 Interventional Results available

A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

NCT02085135
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
8
States / cities
Jacksonville, Florida • Orlando, Florida • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2019 · Synced Sep 3, 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 9, 2015 · Synced Sep 3, 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 7, 2021 · Synced Sep 3, 2026, 5:09 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers

NCT02504463
View directory record Official record
Conditions
Healthy
Interventions
Samidorphan IV, [14c]-Samidorphan sublingual, [14c]-Samidorphan oral
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Sep 17, 2015 · Synced Sep 3, 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 9, 2020 · Synced Sep 3, 2026, 5:09 AM EDT