Trial Outcomes & Findings for Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on) (NCT NCT00868452)

Last Updated: 2014-04-17

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

348 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2014-04-17

Participant Flow

5/11/2009 - 1/9/2012

Participant milestones

Participant milestones
Measure	Lurasidone lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Overall Study STARTED	183	165
Overall Study COMPLETED	143	136
Overall Study NOT COMPLETED	40	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lurasidone n=179 Participants lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo n=161 Participants Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7	Total n=340 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	178 Participants n=5 Participants	155 Participants n=7 Participants	333 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	41.0 years STANDARD_DEVIATION 11.53 • n=5 Participants	42.6 years STANDARD_DEVIATION 11.75 • n=7 Participants	41.7 years STANDARD_DEVIATION 11.65 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	76 Participants n=7 Participants	162 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	85 Participants n=7 Participants	178 Participants n=5 Participants
Region of Enrollment France	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	52 participants n=7 Participants	110 participants n=5 Participants
Region of Enrollment Czech Republic	27 participants n=5 Participants	21 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment Poland	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Ukraine	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Romania	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment South Africa	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Russian Federation	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment India	43 participants n=5 Participants	37 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Full analysis set (intent-to-treat population)

Outcome measures

Outcome measures
Measure	Lurasidone n=179 Participants lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo n=161 Participants Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)	-17.1 units on a scale Standard Error 0.87	-13.5 units on a scale Standard Error 0.91

SECONDARY outcome

Timeframe: Baseline Week 6

Population: Full analyis 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

Outcome measures
Measure	Lurasidone n=179 Participants lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo n=161 Participants Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	-1.96 units on a scale Standard Error 0.104	-1.51 units on a scale Standard Error 0.109

SECONDARY outcome

Timeframe: Baselin Week 6

Population: Full analysis set (intent-to-treat population)

STS 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

Outcome measures
Measure	Lurasidone n=179 Participants lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo n=161 Participants Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score	-9.5 units on a scale Standard Deviation 0.78	-7.0 units on a scale Standard Deviation 0.81

Adverse Events

Lurasidone

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lurasidone n=183 participants at risk lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo n=163 participants at risk Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Psychiatric disorders Suicidal Ideation	0.55% 1/183 • Number of events 1 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	0.61% 1/163 • Number of events 1 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Psychiatric disorders Depression	0.55% 1/183 • Number of events 1 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	0.00% 0/163 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/183 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	0.61% 1/163 • Number of events 1 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).

Other adverse events

Other adverse events
Measure	Lurasidone n=183 participants at risk lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.	Placebo n=163 participants at risk Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Gastrointestinal disorders Nausea	17.5% 32/183 • Number of events 44 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	11.0% 18/163 • Number of events 24 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Nervous system disorders Headache	10.4% 19/183 • Number of events 30 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	12.3% 20/163 • Number of events 29 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Nervous system disorders Somnolence	9.3% 17/183 • Number of events 17 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	4.3% 7/163 • Number of events 9 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Nervous system disorders Tremor	8.2% 15/183 • Number of events 17 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	4.3% 7/163 • Number of events 8 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Nervous system disorders Akathisia	7.7% 14/183 • Number of events 18 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	4.3% 7/163 • Number of events 10 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Psychiatric disorders Insomnia	7.1% 13/183 • Number of events 21 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	5.5% 9/163 • Number of events 11 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
Gastrointestinal disorders Diarrhea	4.4% 8/183 • Number of events 10 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).	6.7% 11/163 • Number of events 12 • Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).

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