Trial Outcomes & Findings for Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (NCT NCT01284517)
NCT ID: NCT01284517
Last Updated: 2013-11-26
Results Overview
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
Baseline to week 6
Results posted on
2013-11-26
Participant Flow
Participant milestones
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
|
Placebo + Li/VPA
Placebo + Lithium/divalproex
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
176
|
|
Overall Study
COMPLETED
|
148
|
140
|
|
Overall Study
NOT COMPLETED
|
32
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Baseline characteristics by cohort
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
n=176 Participants
|
Placebo + Li/VPA
n=166 Participants
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
166 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
43.1 years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 11.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
63 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
India
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 6Population: Full analysis set (intent-to-treat population)
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Outcome measures
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
n=176 Participants
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
|
Placebo + Li/VPA
n=166 Participants
Placebo (PO) + Lithium or divalproex
|
|---|---|---|
|
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
|
-11.8 units on a scale
Standard Error 0.76
|
-10.4 units on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: Full analysis set (intent-to-treat population)
CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Outcome measures
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
n=176 Participants
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
|
Placebo + Li/VPA
n=166 Participants
Placebo (PO) + Lithium or divalproex
|
|---|---|---|
|
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
|
-1.36 units on a scale
Standard Error 0.099
|
-1.13 units on a scale
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: Full analysis set (intent-to-treat population)
SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Outcome measures
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
n=176 Participants
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
|
Placebo + Li/VPA
n=166 Participants
Placebo (PO) + Lithium or divalproex
|
|---|---|---|
|
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
|
-5.4 units on a scale
Standard Error 0.85
|
-5.4 units on a scale
Standard Error 0.74
|
Adverse Events
Lurasidone 20-120 mg Flexible Dose+Li/VPA
Serious events: 5 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo + Li/VPA
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
n=177 participants at risk
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
|
Placebo + Li/VPA
n=171 participants at risk
Placebo (PO)+ Lithium/divalproex
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Immune system disorders
Anaphylactic Shock
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
General disorders
Disease Progression
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Psychiatric disorders
Depression Suicidal
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.56%
1/177 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.00%
0/171 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Psychiatric disorders
Mania
|
0.00%
0/177 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.58%
1/171 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/177 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.58%
1/171 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/177 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
0.58%
1/171 • Number of events 1 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
Other adverse events
| Measure |
Lurasidone 20-120 mg Flexible Dose+Li/VPA
n=177 participants at risk
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
|
Placebo + Li/VPA
n=171 participants at risk
Placebo (PO)+ Lithium/divalproex
|
|---|---|---|
|
Nervous system disorders
Akathisia
|
14.1%
25/177 • Number of events 29 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
5.3%
9/171 • Number of events 12 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
18/177 • Number of events 25 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
9.4%
16/171 • Number of events 20 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
8.5%
15/177 • Number of events 18 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
8.8%
15/171 • Number of events 16 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
8.5%
15/177 • Number of events 16 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
10.5%
18/171 • Number of events 19 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
8.5%
15/177 • Number of events 16 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
2.9%
5/171 • Number of events 6 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
14/177 • Number of events 15 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
5.8%
10/171 • Number of events 13 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
6.2%
11/177 • Number of events 14 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
5.3%
9/171 • Number of events 9 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
5.1%
9/177 • Number of events 9 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
5.3%
9/171 • Number of events 9 • 13 December 2010 to 7 August 2012
Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
|
Additional Information
Medical Director, CNS
Sunovion
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