Trial Outcomes & Findings for A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (NCT NCT01143090)

NCT ID: NCT01143090

Last Updated: 2015-06-12

Results Overview

Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 149 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-06-12

Participant Flow

FPI August 10, 2010-LPV November 28, 2011, locations were private health clinics, university hospitals, private research facilities.

Participant milestones

Measure	Open Label Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
Overall Study STARTED	149
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Measure	Open Label Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
Overall Study Lack of Efficacy	2
Overall Study Adverse Event	17
Overall Study Lost to Follow-up	9
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	18
Overall Study Non-compliance with study drug	1
Overall Study Failure to meet eligibility criteria	1
Overall Study Administrative	1

Baseline Characteristics

A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder

Baseline characteristics by cohort

Measure	Open Label n=148 Participants Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	146 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.8 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants
Region of Enrollment United States	148 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Safety population - One enrolled subject did not receive any study medication and was excluded from this summary.

Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.

Outcome measures

Measure	Lurasidone Overall n=148 Participants
Adverse Events Any Treatment Emergent Adverse Event	98 participants
Adverse Events Any Severe Treatment Emergent Adverse Event	10 participants
Adverse Events Treatment Emergent AE Leading to Discontinuation	16 participants

SECONDARY outcome

Timeframe: 6 months

Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289

Outcome measures

Outcome data not reported

Adverse Events

Open Label

Serious events: 8 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open Label n=148 participants at risk Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
Psychiatric disorders Schizoaffective Disorder	2.0% 3/148 • Number of events 3
Psychiatric disorders Schizophrenia	1.4% 2/148 • Number of events 2
Psychiatric disorders Suicidal Ideation	1.4% 2/148 • Number of events 2
Psychiatric disorders Bipolar I Disorder	0.68% 1/148 • Number of events 1
Psychiatric disorders Homicidal Ideation	0.68% 1/148 • Number of events 1
Psychiatric disorders Paranoia	0.68% 1/148 • Number of events 1

Other adverse events

Measure	Open Label n=148 participants at risk Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
Gastrointestinal disorders Nausea	8.8% 13/148 • Number of events 15
Psychiatric disorders Insomnia	8.8% 13/148 • Number of events 13
Nervous system disorders Akathisia	8.1% 12/148 • Number of events 12
Psychiatric disorders Anxiety	6.1% 9/148 • Number of events 9

Additional Information

Medical Director, CNS

Sunovion Pharmaceuticals Inc

Phone: 1-866-503-6351

Results disclosure agreements

• Principal investigator is a sponsor employee In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
• Publication restrictions are in place

Restriction type: OTHER