Trial Outcomes & Findings for A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder (NCT NCT02161718)

Last Updated: 2021-10-08

Results Overview

EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization (includes psychiatric\& treatment of alcohol intoxication/withdrawal) 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

Up to 15 months

Results posted on

2021-10-08

Participant Flow

Subjects were adults with a diagnosis of schizophrenia and Alcohol Use Disorder (AUD). Subjects must also have recently experienced an exacerbation of disease symptoms (eg, hospitalization), but could not exceed a pre-defined level of symptom severity at the time of screening (as measured by assessments like the Positive and Negative Symptom Scale \[PANSS\] and Clinical Global Impression- Severity \[CGI-S\]).

After screening, subjects began a 4-week open-label olanzapine dosing period followed by a 2- week open-label ALKS 3831 period. Subjects who did not tolerate ALKS 3831 during the second open-label period were discontinued from the study prior to randomization. A total of 300 subjects were enrolled in the study, and 255 completed the open-label olanzapine period. 234 subjects were randomized following the open-label ALKS 3831 period, however, 5 subjects discontinued prior to receiving treatment.

Participant milestones

Participant milestones
Measure	Open-label ALKS 3831 Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	ALKS 3831 Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	Olanzapine + Placebo Oral tablet, taken once daily Olanzapine dose level determined by investigator
Open-Label ALKS 3831 Period STARTED	255	0	0
Open-Label ALKS 3831 Period COMPLETED	234	0	0
Open-Label ALKS 3831 Period NOT COMPLETED	21	0	0
Post- Randomization Period STARTED	0	112	117
Post- Randomization Period COMPLETED	0	53	58
Post- Randomization Period NOT COMPLETED	0	59	59

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label ALKS 3831 Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	ALKS 3831 Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	Olanzapine + Placebo Oral tablet, taken once daily Olanzapine dose level determined by investigator
Open-Label ALKS 3831 Period Protocol Violation	2	0	0
Open-Label ALKS 3831 Period Physician Decision	1	0	0
Open-Label ALKS 3831 Period Non-compliance with study drug	1	0	0
Open-Label ALKS 3831 Period Lack of Efficacy	1	0	0
Open-Label ALKS 3831 Period Adverse Event	3	0	0
Open-Label ALKS 3831 Period Withdrawal by Subject	4	0	0
Open-Label ALKS 3831 Period Lost to Follow-up	3	0	0
Open-Label ALKS 3831 Period Failure to meet randomization criteria	6	0	0
Post- Randomization Period Withdrawal by Subject	0	23	18
Post- Randomization Period Lost to Follow-up	0	9	15
Post- Randomization Period Adverse Event	0	9	10
Post- Randomization Period Non- compliance with study drug	0	8	2
Post- Randomization Period Physician Decision	0	2	4
Post- Randomization Period Protocol Violation	0	2	3
Post- Randomization Period Lack of Efficacy	0	0	1
Post- Randomization Period Non-compliance with study procedures	0	2	4
Post- Randomization Period Received prohibitive treatment	0	1	2
Post- Randomization Period Relocation	0	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALKS 3831 n=112 Participants Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	Olanzapine + Placebo n=117 Participants Oral tablet, taken once daily Olanzapine dose level determined by investigator	Total n=229 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 10.60 • n=5 Participants	45.1 years STANDARD_DEVIATION 10.22 • n=7 Participants	45.7 years STANDARD_DEVIATION 10.40 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	91 Participants n=7 Participants	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	109 Participants n=7 Participants	217 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	65 Participants n=5 Participants	57 Participants n=7 Participants	122 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	58 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants	76 participants n=7 Participants	161 participants n=5 Participants
Region of Enrollment Bulgaria	24 participants n=5 Participants	36 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment Poland	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Height	173.4 centimeters STANDARD_DEVIATION 9.6 • n=5 Participants	174.4 centimeters STANDARD_DEVIATION 8.4 • n=7 Participants	173.9 centimeters STANDARD_DEVIATION 9.0 • n=5 Participants
Weight	86.2 kilograms STANDARD_DEVIATION 19.7 • n=5 Participants	86.8 kilograms STANDARD_DEVIATION 18.1 • n=7 Participants	86.5 kilograms STANDARD_DEVIATION 18.9 • n=5 Participants
Body Mass Index (BMI)	28.6 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants	28.5 kg/m^2 STANDARD_DEVIATION 5.4 • n=7 Participants	28.6 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants
Body Mass Index (BMI) Group Underweight (<18.5)	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Body Mass Index (BMI) Group Normal (18.5 to <25)	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Body Mass Index (BMI) Group Overweight (25 to <30)	33 Participants n=5 Participants	49 Participants n=7 Participants	82 Participants n=5 Participants
Body Mass Index (BMI) Group Obese (>= 30)	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 15 months

Population: Efficacy analyses were carried out using the intent to treat (ITT) population, i.e. all randomized subjects who received at least one dose of study drug post-randomization

Outcome measures

Outcome measures
Measure	ALKS 3831 n=112 Participants Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	Olanzapine + Placebo n=117 Participants Oral tablet, taken once daily Olanzapine dose level determined by investigator
Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) Number of Subjects with IAC Adjudicated EEDS	25 Participants	29 Participants
Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) Number of Subjects Censored	87 Participants	88 Participants

SECONDARY outcome

Timeframe: Up to 15 months

Population: Efficacy analyses were carried out using the intent to treat (ITT) population, i.e. all randomized subjects who received at least one dose of study drug post-randomization

EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization(includes psychiatric \& treatment of alcohol intoxication/withdrawal) 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease

Outcome measures

Outcome measures
Measure	ALKS 3831 n=112 Participants Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	Olanzapine + Placebo n=117 Participants Oral tablet, taken once daily Olanzapine dose level determined by investigator
Number of Events of Exacerbation of Disease (EEDS)	35 Events	49 Events

SECONDARY outcome

Timeframe: 24 weeks

Population: Efficacy analyses were carried out using subjects from the intent to treat (ITT) population with postbaseline data on drinking habits.

Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days) WHO criteria for risk of alcohol consumption on a single drinking day: Abstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: \>= 101 g; Females: \>= 61 g

Outcome measures

Outcome measures
Measure	ALKS 3831 n=111 Participants Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)	Olanzapine + Placebo n=116 Participants Oral tablet, taken once daily Olanzapine dose level determined by investigator
Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) >= 1 Level Decrease from Baseline	45 Participants	44 Participants
Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) < 1 Level Decrease from Baseline	66 Participants	72 Participants

Adverse Events

Open- Label ALKS 3831

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Olanzapine + Placebo

Serious events: 12 serious events

Other events: 19 other events

Deaths: 1 deaths

ALKS 3831

Serious events: 7 serious events

Other events: 26 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Open- Label ALKS 3831 n=255 participants at risk A 2-week open-label period; all subjects received olanzapine (dose determined by investigator) + 10 mg samidorphan	Olanzapine + Placebo n=117 participants at risk All randomized subjects who received at least 1 dose of study drug (olanzapine + placebo) during the double-blind treatment period	ALKS 3831 n=112 participants at risk All randomized subjects who received at least 1 dose of ALKS 3831 (olanzapine + samidorphan) during the double-blind treatment period.
Investigations Weight increased	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	12.0% 14/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	14.3% 16/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Investigations Alanine aminotransferase increased	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	5.4% 6/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Infections and infestations Nasopharyngitis	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	4.3% 5/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	6.2% 7/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.

Additional Information

Director, Corporate and R&D Communications

Alkermes

Phone: 781-609-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance
Publication restrictions are in place

Restriction type: OTHER

Measure	Open- Label ALKS 3831 n=255 participants at risk A 2-week open-label period; all subjects received olanzapine (dose determined by investigator) + 10 mg samidorphan	Olanzapine + Placebo n=117 participants at risk All randomized subjects who received at least 1 dose of study drug (olanzapine + placebo) during the double-blind treatment period	ALKS 3831 n=112 participants at risk All randomized subjects who received at least 1 dose of ALKS 3831 (olanzapine + samidorphan) during the double-blind treatment period.
Infections and infestations Parotitis	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.85% 1/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.85% 1/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Injury, poisoning and procedural complications Fall	0.39% 1/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Injury, poisoning and procedural complications Laceration	0.39% 1/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Investigations Electrocardiogram abnormal	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.89% 1/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Renal and urinary disorders Chronic obstructive pulmonary disease	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.89% 1/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Nervous system disorders Convulsion	0.39% 1/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Nervous system disorders Dizziness	0.39% 1/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Nervous system disorders Transient ischaemic attack	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.89% 1/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Alcoholism	0.39% 1/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Schizophrenia, paranoid type	0.39% 1/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Schizophrenia	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	3.4% 4/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	2.7% 3/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Paranoia	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.89% 1/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Psychotic disorder	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.89% 1/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Aggression	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.85% 1/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Agitation	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.85% 1/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Disturbance in social behavior	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	1.7% 2/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Psychiatric disorders Suicidal ideation	0.00% 0/255 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	2.6% 3/117 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.	0.00% 0/112 • Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.