Trial Outcomes & Findings for A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia (NCT NCT00088634)

Last Updated: 2016-04-08

Results Overview

The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

180 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2016-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Lurasidone 80 mg 2 40 mg lurasidone tablets taken once/day	Placebo Matching placebo to lurasidone 40 mg tablets taken once/day
Overall Study STARTED	90	90
Overall Study COMPLETED	52	47
Overall Study NOT COMPLETED	38	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lurasidone 80 mg n=90 Participants 2 40 mg lurasidone tablets taken once/day	Placebo n=90 Participants Matching placebo to lurasidone 40 mg tablets taken once/day	Total n=180 Participants Total of all reporting groups
Age, Continuous	39.7 years STANDARD_DEVIATION 9.91 • n=5 Participants	41.9 years STANDARD_DEVIATION 9.78 • n=7 Participants	40.8 years STANDARD_DEVIATION 9.88 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	70 Participants n=7 Participants	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.

Outcome measures

Outcome measures
Measure	Lurasidone 80 mg n=90 Participants 2 40 mg lurasidone tablets taken once/day	Placebo n=90 Participants Matching placebo to lurasidone 40 mg tablets taken once/day
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score	-8.9 units on a scale Interval -11.5 to -6.2	-4.2 units on a scale Interval -6.9 to -1.5

SECONDARY outcome

Timeframe: Baseline and 6 weeks

The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.

Outcome measures

Outcome measures
Measure	Lurasidone 80 mg n=90 Participants 2 40 mg lurasidone tablets taken once/day	Placebo n=90 Participants Matching placebo to lurasidone 40 mg tablets taken once/day
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	-14.1 units on a scale Interval -18.3 to -9.9	-5.5 units on a scale Interval -9.8 to -1.2

SECONDARY outcome

Timeframe: Baseline and 6 weeks

The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Outcome measures

Outcome measures
Measure	Lurasidone 80 mg n=90 Participants 2 40 mg lurasidone tablets taken once/day	Placebo n=90 Participants Matching placebo to lurasidone 40 mg tablets taken once/day
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores	-0.6 units on a scale Interval -0.8 to -0.4	-0.2 units on a scale Interval -0.4 to 0.0

SECONDARY outcome

Timeframe: Baseline and 6 weeks

The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

Outcome measures

Outcome measures
Measure	Lurasidone 80 mg n=86 Participants 2 40 mg lurasidone tablets taken once/day	Placebo n=83 Participants Matching placebo to lurasidone 40 mg tablets taken once/day
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores	-2.9 units on scale Interval -4.6 to -1.3	-0.1 units on scale Interval -1.9 to 1.6

Adverse Events

Lurasidone 80 mg

Serious events: 2 serious events

Other events: 53 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lurasidone 80 mg n=90 participants at risk 2 40 mg lurasidone tablets taken once/day	Placebo n=90 participants at risk Matching placebo to lurasidone 40 mg tablets taken once/day
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/90	1.1% 1/90 • Number of events 1
Psychiatric disorders Schizophrenia NOS	2.2% 2/90 • Number of events 2	1.1% 1/90 • Number of events 1
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Airways Disease	0.00% 0/90	1.1% 1/90 • Number of events 1

Other adverse events

Other adverse events
Measure	Lurasidone 80 mg n=90 participants at risk 2 40 mg lurasidone tablets taken once/day	Placebo n=90 participants at risk Matching placebo to lurasidone 40 mg tablets taken once/day
Gastrointestinal disorders Constipation	11.1% 10/90 • Number of events 10	5.6% 5/90 • Number of events 5
Gastrointestinal disorders Dyspepsia	7.8% 7/90 • Number of events 7	3.3% 3/90 • Number of events 3
Gastrointestinal disorders Nausea	16.7% 15/90 • Number of events 15	3.3% 3/90 • Number of events 3
Gastrointestinal disorders Toothache	5.6% 5/90 • Number of events 5	3.3% 3/90 • Number of events 3
Gastrointestinal disorders Vomiting	11.1% 10/90 • Number of events 10	5.6% 5/90 • Number of events 5
Infections and infestations Upper Respiratory Tract Infection	3.3% 3/90 • Number of events 3	6.7% 6/90 • Number of events 6
Musculoskeletal and connective tissue disorders Back Pain	3.3% 3/90 • Number of events 3	5.6% 5/90 • Number of events 5
Nervous system disorders Akathisia	8.9% 8/90 • Number of events 8	3.3% 3/90 • Number of events 3
Nervous system disorders Headache	11.1% 10/90 • Number of events 10	10.0% 9/90 • Number of events 9
Nervous system disorders Sedation	10.0% 9/90 • Number of events 9	4.4% 4/90 • Number of events 4
Nervous system disorders Somnolence	11.1% 10/90 • Number of events 10	3.3% 3/90 • Number of events 3
Psychiatric disorders Anxiety	6.7% 6/90 • Number of events 6	1.1% 1/90 • Number of events 1
Psychiatric disorders Insomnia	10.0% 9/90 • Number of events 9	3.3% 3/90 • Number of events 3

Additional Information

Josephine Cucchiaro, Executive Director

Sunovion

Phone: 201-592-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place