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

• ALKS 3831 (Drug): Olanzapine + samidorphan, daily oral dosing

Primary outcomes

• Incidence of Adverse Events [Up to 48 months]
• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale [Up to 48 months]: The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients

Sex: All, ages: 16 Years to 70 Years

Inclusion Criteria:

* Willing and able to give informed consent/assent as per local requirements
* Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
* Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
* Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
* Additional criteria may apply

Exclusion Criteria:

* Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
* Has a positive drug screen for drugs of abuse at study entry
* Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
* Additional criteria may apply

Participant flow

Outcome results

• Incidence of Adverse Events (Primary), Count of participants, Participants: ALKS 3831 314
• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale (Primary), Mean, units on a scale: ALKS 3831 -.24 +/- .651

Adverse events

Time frame: Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);

Serious adverse events by term

Other adverse events by term

• Results publication: Ballon JS, Kahn RS, Arevalo C, Dunbar M, McDonnell D, Correll CU. Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. J Clin Psychiatry. 2024 Dec 4;86(1):24m15511. doi: 10.4088/JCP.24m15511. PMID 39630083

• Study Protocol (PDF, 2019-05-09)
• Statistical Analysis Plan (PDF, 2023-06-13)

• Alkermes Medical Director, Study director, Alkermes, Inc.