ALKS 3831

DRUG7 trials

Sponsors

Alkermes, Inc.

Conditions

Bipolar I DisorderHealthy VolunteersSchizophreniaSchizophreniform DisorderSchizophreniform Disorders

Phase 1

A Phase 1 Safety Study in Adults With Schizophrenia

CompletedNCT02804568

Alkermes, Inc.Schizophrenia

Start: 2016-06-30End: 2016-08-31Updated: 2016-09-22

An Insulin Sensitivity Study in Healthy Subjects

CompletedNCT02922426

Alkermes, Inc.Healthy Volunteers

Start: 2016-09-30End: 2017-07-20Updated: 2017-08-22

Phase 3

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

CompletedNCT02669758

Alkermes, Inc.Schizophrenia

Start: 2016-01-20End: 2018-06-29Updated: 2019-07-26

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

CompletedNCT02694328

Alkermes, Inc.Schizophrenia

Start: 2016-03-02End: 2018-11-07Updated: 2020-02-10

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

CompletedNCT02873208

Alkermes, Inc.Schizophrenia

Start: 2016-08-07End: 2019-10-17Updated: 2021-07-21

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

CompletedNCT03187769

Alkermes, Inc.Bipolar I Disorder, Schizophrenia, Schizophreniform Disorders

Start: 2017-06-08End: 2022-01-03Updated: 2023-01-19

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

CompletedNCT03201757

Alkermes, Inc.Bipolar I Disorder, Schizophrenia, Schizophreniform Disorder

Start: 2017-06-15End: 2023-09-06Updated: 2024-09-26

Related Papers

Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan

The Journal of Clinical Psychiatry2024-12-045 citations

Using qualitative exit interviews to explore schizophrenia burden and treatment experience in clinical trial patients

Frontiers in Psychiatry2024-08-212 citations

Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness

The Journal of Clinical Psychiatry2023-03-1613 citations

Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study

Schizophrenia Bulletin2022-10-2824 citations

Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients

CNS Spectrums2022-10-138 citations

A phase 3, multicenter study to assess the 1-year safety and tolerability of a combination of olanzapine and samidorphan in patients with schizophrenia: Results from the ENLIGHTEN-2 long-term extension.

2021-05-1726 citations

Phase 3 Safety and Tolerability Results of the Combination Olanzapine and Samidorphan in Patients with Schizophrenia: The 1 Year ENLIGHTEN-2-Extension

CNS Spectrums2021-04-012 citations

Qualitative Clinical Trial Exit Interviews Evaluating Treatment Benefit, Burden, and Satisfaction in Patients with Schizophrenia

CNS Spectrums2021-04-012 citations

100 Olanzapine/Samidorphan for Schizophrenia: Weight Gain and Metabolic Outcomes in Phase 3 ENLIGHTEN-2 and Subsequent Long-Term, Open-Label Safety Study

CNS Spectrums2020-04-011 citations

Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia

Clinical Therapeutics2018-10-2037 citations

S226. A STUDY COMPARING WEIGHT GAIN FROM ALKS 3831 TO OLANZAPINE IN EARLY-ILLNESS YOUNG ADULTS WITH SCHIZOPHRENIFORM, SCHIZOPHRENIA, OR BIPOLAR I DISORDER

Schizophrenia Bulletin2018-04-011 citations