Trial Outcomes & Findings for This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months (NCT NCT03351244)

Last Updated: 2025-05-14

Results Overview

The incidence rate of first relapse after 28 weeks of treatment is reported. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

264 participants

Primary outcome timeframe

28 weeks

Results posted on

2025-05-14

Participant Flow

This Phase II trial aimed to evaluate the impact of 28-week treatment with BI 409306 (added to standard antipsychotic medication) compared with placebo on preventing relapse in patients with schizophrenia.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	BI 409306 25 mg 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	Placebo 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Overall Study STARTED	89	88	87
Overall Study COMPLETED	62	48	53
Overall Study NOT COMPLETED	27	40	34

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 409306 25 mg 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	Placebo 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Overall Study Adverse Event	7	11	12
Overall Study Investigator's decision	0	0	2
Overall Study System error	0	0	2
Overall Study COVID-19 restrictions	3	0	1
Overall Study Non-compliance	2	5	0
Overall Study Withdrawal by Subject	11	16	13
Overall Study Lost to Follow-up	2	6	4
Overall Study Protocol Violation	2	2	0

Baseline Characteristics

This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 409306 25 mg n=89 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=88 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	Placebo n=87 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.	Total n=264 Participants Total of all reporting groups
Age, Continuous	38.4 Years STANDARD_DEVIATION 9.8 • n=93 Participants	41.9 Years STANDARD_DEVIATION 9.6 • n=4 Participants	40.5 Years STANDARD_DEVIATION 9.8 • n=27 Participants	40.3 Years STANDARD_DEVIATION 9.8 • n=483 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	36 Participants n=4 Participants	32 Participants n=27 Participants	97 Participants n=483 Participants
Sex: Female, Male Male	60 Participants n=93 Participants	52 Participants n=4 Participants	55 Participants n=27 Participants	167 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=93 Participants	15 Participants n=4 Participants	15 Participants n=27 Participants	40 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=93 Participants	69 Participants n=4 Participants	68 Participants n=27 Participants	212 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	12 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	23 Participants n=93 Participants	20 Participants n=4 Participants	20 Participants n=27 Participants	63 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Black or African American	36 Participants n=93 Participants	37 Participants n=4 Participants	32 Participants n=27 Participants	105 Participants n=483 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants	24 Participants n=4 Participants	25 Participants n=27 Participants	72 Participants n=483 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants	18 Participants n=483 Participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Full analysis set (FAS): the FAS includes all patients in the treated set with at least 1 baseline and post-baseline measurement of any type.

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=89 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=88 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=177 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=87 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Incidence Rate of First Relapse After 28 Weeks of Treatment	0.527 Events per patient-years	0.434 Events per patient-years	0.482 Events per patient-years	0.496 Events per patient-years

SECONDARY outcome

Timeframe: At baseline and at Week 28.

Population: Full analysis set (FAS): the FAS includes all patients in the treated set with at least 1 baseline and post-baseline measurement of any type. Only participants with non-missing results were included in the analysis.

Positive and Negative Syndrome Scale (PANSS): assesses the severity of psychotic symptoms and progression of disease. The PANSS positive symptoms score is the sum of scores from 7 Items where each item has a minimum score 1 (better outcome) and maximum score 7 (worse outcome). The PANSS positive symptoms score ranges from 7 (less severe the disease) to 49 (more severe the disease).

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=73 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=55 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=128 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=65 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Symptoms Score After 28 Weeks of Treatment	-0.54 Score on a scale Interval -1.37 to 0.294	-0.71 Score on a scale Interval -1.641 to 0.224	-0.61 Score on a scale Interval -1.231 to 0.005	-0.92 Score on a scale Interval -1.769 to -0.07

SECONDARY outcome

Timeframe: At baseline and at Week 28

Clinical Global Impressions-Severity (CGI-S): One-item evaluation completed by the clinician to measure the severity of psychopathology. The CGI-S score ranges from 1 (normal) through to 7 (most severely ill). The higher the score, the worse the psychopathology.

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=73 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=55 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=128 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=65 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 28 Weeks of Treatment	-0.15 Score on a scale Standard Deviation 0.758	-0.22 Score on a scale Standard Deviation 0.839	-0.18 Score on a scale Standard Deviation 0.791	-0.22 Score on a scale Standard Deviation 0.718

SECONDARY outcome

Timeframe: At Week 28

Patient Global Impressions-Improvement (PGI-I): One-item evaluation completed by the patient to assess their overall evaluation of his/her status compared to how they felt at randomisation. The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The higher the score, the worse the improvement.

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=72 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=54 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=126 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=63 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Patient Global Impressions-Improvement (PGI-I) Scale Score After 28 Weeks of Treatment	2.61 Score on a scale Standard Deviation 1.328	2.96 Score on a scale Standard Deviation 1.197	2.76 Score on a scale Standard Deviation 1.280	2.94 Score on a scale Standard Deviation 1.190

SECONDARY outcome

Timeframe: 28 weeks

Population: Full analysis set (FAS): the FAS includes all patients in the treated set with at least 1 baseline and post-baseline measurement of any type.

Columbia Suicide Severity Rating Scale (C-SSRS): suicide risk assessment. At a minimum, the interview consists of 2 screening questions related to suicidal ideation and 4 related to suicidal behavior, and may be expanded to up to 17 items in case of positive responses. Free text entries are allowed. Suicidal behavior is collected in nominal scale as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior. Suicidal ideation is rated on a 6-point scale from 0 (No ideation present) to 5 (Active ideation with plan and intent). A score of 4 or 5 on this scale indicates serious suicidal ideation. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=89 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=88 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=177 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=87 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Incidence Rate of Suicidal Ideation and Behaviour (Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)) After 28 Weeks of Treatment	0.070 Events per patient-years	0.077 Events per patient-years	0.073 Events per patient-years	0.071 Events per patient-years

SECONDARY outcome

Timeframe: At baseline and at Week 28

Personal and Social Performance scale (PSP): The PSP is a 100-point, single item, clinician rated scale to assess 4 domains of social functioning (Four domains over the past month: (1) socially useful activities, (2) personal and social relationships, (3) self-care and (4) disturbing and aggressive behaviors.) in patients with schizophrenia. The PSP score is a single score ranging from 1 to 100. Higher scores represent better personal and social functioning.

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=72 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=54 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=126 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=65 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Change From Baseline in Personal and Social Performance Scale (PSP) Score After 28 Weeks of Treatment	2.8 Score on a scale Standard Deviation 8.8	2.4 Score on a scale Standard Deviation 9.4	2.6 Score on a scale Standard Deviation 9.1	3.0 Score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: 28 weeks

Population: Full analysis set (FAS): the FAS includes all patients in the treated set with at least 1 baseline and post-baseline measurement of any type.

The incidence rate of new prescription or increase in dose of an ongoing antipsychotic medication is reported. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

Outcome measures

Outcome measures
Measure	BI 409306 25 mg n=89 Participants 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=88 Participants 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 Pooled n=177 Participants This group included all participants who administered BI 409306 during the study.	Placebo n=87 Participants 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.
Incidence Rate of New Prescription or Increase in Dose of an Ongoing Antipsychotic Medication	0.168 Events per patient-years	0.130 Events per patient-years	0.149 Events per patient-years	0.217 Events per patient-years

Adverse Events

BI 409306 25 mg

Serious events: 9 serious events

Other events: 30 other events

Deaths: 0 deaths

BI 409306 50 mg

Serious events: 7 serious events

Other events: 25 other events

Deaths: 1 deaths

Placebo

Serious events: 12 serious events

Other events: 19 other events

Deaths: 0 deaths

Total

Serious events: 28 serious events

Other events: 74 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BI 409306 25 mg n=89 participants at risk 1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	BI 409306 50 mg n=88 participants at risk 1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period. Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.	Placebo n=87 participants at risk 1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks. Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups. Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period.	Total n=264 participants at risk All participants randomised in this study.
Eye disorders Photophobia	3.4% 3/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	9.1% 8/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	1.1% 1/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	4.5% 12/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Gastrointestinal disorders Vomiting	1.1% 1/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	1.1% 1/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	5.7% 5/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	2.7% 7/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Infections and infestations Nasopharyngitis	7.9% 7/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	5.7% 5/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	8.0% 7/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	7.2% 19/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Nervous system disorders Headache	6.7% 6/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	8.0% 7/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	4.6% 4/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	6.4% 17/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Nervous system disorders Somnolence	5.6% 5/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	3.4% 3/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	3.4% 3/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	4.2% 11/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Psychiatric disorders Insomnia	5.6% 5/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	6.8% 6/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	0.00% 0/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	4.2% 11/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Psychiatric disorders Schizophrenia	6.7% 6/89 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	4.5% 4/88 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	2.3% 2/87 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.	4.5% 12/264 • All-cause mortality: From first dose until withdraw or end of 1-week taper period + 3-week follow-up period, up to 32 weeks. Serious (non-serious) adverse events: From first dose until withdraw or end of 1-week taper period + 1-week residual effect period, up to 30 weeks. Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.

Additional Information

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