Completed PHASE3 INTERVENTIONAL 1-arm NCT03201757

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

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

Sponsor: Alkermes, Inc.

Conditions Bipolar I Disorder Schizophrenia Schizophreniform Disorder

Interventions ALKS 3831

Updated 24 times since 2017 Last updated: Sep 20, 2024 Started: Jun 15, 2017 Primary completion: Sep 6, 2023 Completion: Sep 6, 2023

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Bipolar I Disorder and Schizophrenia, this trial is completed. The trial is conducted by Alkermes, Inc. and has accumulated 24 data snapshots since 2017. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

Change History

24 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Dec 2025 [monthly]

Completed PHASE3
Oct 2024 — Sep 2025 [monthly]

Completed PHASE3
Sep 2024 — Oct 2024 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3

▶ Show 19 earlier versions

Mar 2024 — Jul 2024 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Oct 2023 — Mar 2024 [monthly]

Active Not Recruiting PHASE3
Mar 2022 — Oct 2023 [monthly]

Active Not Recruiting PHASE3

Status: Enrolling By Invitation → Active Not Recruiting
Nov 2021 — Mar 2022 [monthly]

Enrolling By Invitation PHASE3
Sep 2021 — Nov 2021 [monthly]

Enrolling By Invitation PHASE3
Jun 2021 — Sep 2021 [monthly]

Enrolling By Invitation PHASE3
May 2021 — Jun 2021 [monthly]

Enrolling By Invitation PHASE3
Jan 2021 — May 2021 [monthly]

Enrolling By Invitation PHASE3
Nov 2020 — Jan 2021 [monthly]

Enrolling By Invitation PHASE3
Jun 2020 — Nov 2020 [monthly]

Enrolling By Invitation PHASE3
Sep 2019 — Jun 2020 [monthly]

Enrolling By Invitation PHASE3
Feb 2019 — Sep 2019 [monthly]

Enrolling By Invitation PHASE3
Aug 2018 — Feb 2019 [monthly]

Enrolling By Invitation PHASE3
Jun 2018 — Aug 2018 [monthly]

Enrolling By Invitation PHASE3
Mar 2018 — Jun 2018 [monthly]

Enrolling By Invitation PHASE3
Jan 2018 — Mar 2018 [monthly]

Enrolling By Invitation PHASE3
Nov 2017 — Jan 2018 [monthly]

Enrolling By Invitation PHASE3
Sep 2017 — Nov 2017 [monthly]

Enrolling By Invitation PHASE3
Jul 2017 — Sep 2017 [monthly]

Enrolling By Invitation PHASE3

First recorded

Jun 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Alkermes, Inc.

Data source: Alkermes, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anaheim, United States , Arkhangelsk, Russia , Atlanta, United States , Augusta, United States , Austin, United States , Belgrade, Serbia , Bellevue, United States , Berlin, United States , Brescia, Italy , Brooklyn, United States and 69 more locations