Trial Outcomes & Findings for A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia (NCT NCT00088621)

Last Updated: 2014-04-17

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

1 year

Results posted on

2014-04-17

Participant milestones
Measure	Lurasidone 80 mg Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.
Overall Study STARTED	61
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	54

Withdrawal data not reported

A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

Baseline characteristics by cohort
Measure	Lurasidone 80 mg n=59 Participants Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
Age, Continuous	41.3 years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants

Timeframe: 1 year

Population: Number of subjects that entered into the extension trial.

Outcome measures
Measure	Lurasidone 80 mg n=61 Participants Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study	59 participants

Serious events: 12 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events
Measure	Lurasidone 80 mg n=59 participants at risk Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
Cardiac disorders Pericardial Effusion	1.7% 1/59 • Number of events 1
Infections and infestations Orchitis	1.7% 1/59 • Number of events 1
Infections and infestations Pneumonia	1.7% 1/59 • Number of events 1
Infections and infestations Sepsis	1.7% 1/59 • Number of events 1
Nervous system disorders Cerebrovascular Accident	1.7% 1/59 • Number of events 1
Psychiatric disorders Schizophrenia	13.6% 8/59 • Number of events 8
Psychiatric disorders Self Injurious Behavior	1.7% 1/59 • Number of events 1
Reproductive system and breast disorders Prostatitis	1.7% 1/59 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	1.7% 1/59 • Number of events 1

Other adverse events
Measure	Lurasidone 80 mg n=59 participants at risk Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
Gastrointestinal disorders Nausea	6.8% 4/59 • Number of events 4
Gastrointestinal disorders Vomiting	5.1% 3/59 • Number of events 3
Infections and infestations Bronchitis	6.8% 4/59 • Number of events 4
Infections and infestations Nasopharyngitis	5.1% 3/59 • Number of events 3
Infections and infestations Upper Respiratory Tract Infection	5.1% 3/59 • Number of events 3
Investigations Weight Decreased	5.1% 3/59 • Number of events 3
Investigations Weight Increased	6.8% 4/59 • Number of events 4
Nervous system disorders Sedation	6.8% 4/59 • Number of events 4

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