Trial Outcomes & Findings for A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents (NCT NCT01143077)
NCT ID: NCT01143077
Last Updated: 2013-04-17
Results Overview
Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
6 Weeks
Results posted on
2013-04-17
Participant Flow
FPI June 24, 2010-LPV May 19, 2011, locations were private health clinics, university hospitals, private research facilities.
Participant milestones
| Measure |
Lurasidone Open-Label Arm 40/40
Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
|
Lurasidone Open-Label Arm 40/80
Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
|
Lurasidone Open-Label Arm 80/80
Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
88
|
82
|
|
Overall Study
COMPLETED
|
58
|
73
|
67
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
15
|
Reasons for withdrawal
| Measure |
Lurasidone Open-Label Arm 40/40
Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
|
Lurasidone Open-Label Arm 40/80
Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
|
Lurasidone Open-Label Arm 80/80
Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
5
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
4
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
3
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
1
|
|
Overall Study
Administrative
|
1
|
0
|
0
|
|
Overall Study
Principal Investigator Decision
|
2
|
0
|
1
|
Baseline Characteristics
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Baseline characteristics by cohort
| Measure |
Lurasidone Open-Label Arm 40/40
n=72 Participants
Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
|
Lurasidone Open-Label Arm 40/80
n=87 Participants
Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
|
Lurasidone Open-Label Arm 80/80
n=81 Participants
Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age Continuous
|
43.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
87 participants
n=7 Participants
|
81 participants
n=5 Participants
|
240 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: Intend to treat
Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event
Outcome measures
| Measure |
Lurasidone Open-Label Arm 40/40
n=72 Participants
Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
|
Lurasidone Open-Label Arm 40/80
n=87 Participants
Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
|
Lurasidone Open-Label Arm 80/80
n=81 Participants
Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
|
|---|---|---|---|
|
Time to Relapse of Psychotic Symptoms During 6 Weeks
|
23.8 days
Standard Deviation 12.1
|
16.9 days
Standard Deviation 11.6
|
17.3 days
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 6 WeeksNumber of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Outcome measures
| Measure |
Lurasidone Open-Label Arm 40/40
n=72 Participants
Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
|
Lurasidone Open-Label Arm 40/80
n=87 Participants
Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
|
Lurasidone Open-Label Arm 80/80
n=81 Participants
Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
|
|---|---|---|---|
|
Tolerability and Safety
|
72 participants
|
87 participants
|
81 participants
|
Adverse Events
Lurasidone Open-Label Arm 40/40
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Lurasidone Open-Label Arm 40/80
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Lurasidone Open-Label Arm 80/80
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone Open-Label Arm 40/40
n=72 participants at risk
Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
|
Lurasidone Open-Label Arm 40/80
n=87 participants at risk
Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
|
Lurasidone Open-Label Arm 80/80
n=81 participants at risk
Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/72 • Number of events 1
|
0.00%
0/87
|
0.00%
0/81
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/72
|
1.1%
1/87 • Number of events 1
|
0.00%
0/81
|
|
Psychiatric disorders
Schizoaffective disorder
|
2.8%
2/72 • Number of events 2
|
0.00%
0/87
|
0.00%
0/81
|
|
Psychiatric disorders
Schizophrenia
|
1.4%
1/72 • Number of events 1
|
0.00%
0/87
|
0.00%
0/81
|
|
Psychiatric disorders
Sexually inappropriate behavior
|
0.00%
0/72
|
1.1%
1/87 • Number of events 1
|
0.00%
0/81
|
Other adverse events
| Measure |
Lurasidone Open-Label Arm 40/40
n=72 participants at risk
Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
|
Lurasidone Open-Label Arm 40/80
n=87 participants at risk
Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
|
Lurasidone Open-Label Arm 80/80
n=81 participants at risk
Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.9%
10/72 • Number of events 17
|
9.2%
8/87 • Number of events 8
|
18.5%
15/81 • Number of events 23
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
4/72 • Number of events 4
|
6.9%
6/87 • Number of events 7
|
8.6%
7/81 • Number of events 10
|
|
Gastrointestinal disorders
Dry Mouth
|
4.2%
3/72 • Number of events 3
|
10.3%
9/87 • Number of events 10
|
2.5%
2/81 • Number of events 2
|
|
General disorders
Fatigue
|
4.2%
3/72 • Number of events 3
|
5.7%
5/87 • Number of events 5
|
2.5%
2/81 • Number of events 2
|
|
Nervous system disorders
Akathisia
|
8.3%
6/72 • Number of events 6
|
14.9%
13/87 • Number of events 17
|
13.6%
11/81 • Number of events 13
|
|
Nervous system disorders
Headache
|
9.7%
7/72 • Number of events 13
|
11.5%
10/87 • Number of events 10
|
7.4%
6/81 • Number of events 8
|
|
Nervous system disorders
Sedation
|
4.2%
3/72 • Number of events 3
|
2.3%
2/87 • Number of events 2
|
6.2%
5/81 • Number of events 5
|
|
Nervous system disorders
Somnolence
|
9.7%
7/72 • Number of events 9
|
8.0%
7/87 • Number of events 7
|
2.5%
2/81 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
5.6%
4/72 • Number of events 4
|
0.00%
0/87
|
0.00%
0/81
|
|
Psychiatric disorders
Anxiety
|
2.8%
2/72 • Number of events 2
|
6.9%
6/87 • Number of events 6
|
1.2%
1/81 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/72 • Number of events 4
|
18.4%
16/87 • Number of events 16
|
14.8%
12/81 • Number of events 12
|
Additional Information
Medical Director, CNS
Sunovion Pharmaceuticals
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