RESOLVE3: Major Depressive Disorder With Mixed Features - Extension

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01423253
• Collaborator: (none)
• Enrollment: 48
• Locations: 17
• Arm: 1
• Duration (Months): 25
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Lurasidone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lurasidone 20, 40, 60 mg Lurasidone 20, 40, or 60 mg/day flexibly dosed	Drug: Lurasidone; Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed; Other Names: Latuda

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) [12 Weeks]

   Percentage of subjects with treatment emergent adverse events (TEAEs)

2. Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) [12 Weeks]

   Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)

3. Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) [12 Weeks]

   Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

1. Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores [Baseline to12 Weeks]

   Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.

2. Change From Baseline to Week 12 (LOCF) in CGI-S Score [baseline to week 12]

   The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.

3. Change From Baseline to Week 12 (LOCF) in the YMRS Total Score [Baseline to week 12]

   The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.

4. Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score [Baseline to week 12]

   The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.

5. Change From Baseline to Week 12 (LOCF) in the SDS Total Score [Baseline to week 12]

   The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).

Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Psychiatry Pharmaceutical Studies, Inc	Birmingham	Alabama	United States	35226
2	Synergy Clinical Research Center	Escondido	California	United States	92025
3	Collaborative Neuro Science Network, Inc.	Garden Grove	California	United States	92845
4	Stanford -VA Palo Alto Health Care System	Palo Alto	California	United States	94304
5	Artemis Institute for Clinical Research	San Diego	California	United States	92123
6	Florida Clinical Research Center, LLC	Sarasota	Florida	United States	34201
7	Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders	Boston	Massachusetts	United States	02114
8	St. Charles Psychiatric Associates/Midwest Research Group	St. Charles	Missouri	United States	63301
9	Village Clinical Research Inc.	New York	New York	United States	10003
10	Finger Lakes Clinical Research	Rochester	New York	United States	14618
11	Behavioral Medical Research of Staten Island	Staten Island	New York	United States	10305
12	Psychiatry and Behavioral Sciences, Duke	Durham	North Carolina	United States	27705
13	Midwest Clinical Research Center	Dayton	Ohio	United States	45408
14	CRI Worldwide - Kirkbride	Philadelphia	Pennsylvania	United States	19139
15	FutureSearch Trials of Dallas, LP	Dallas	Texas	United States	75231
16	Dept. of Psychiatry, UT Southwestern Medical Center	Dallas	Texas	United States	75390-8849
17	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: Medical Director, MD, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01423253
• Other Study ID Numbers: D1050306
• First Posted: Aug 25, 2011
• Last Update Posted: Apr 8, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Sunovion: Depression; Lurasidone; Latuda
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Lurasidone Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Period Title: Overall Study
STARTED	48
COMPLETED	39
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Overall Participants	48
Age (Count of Participants)
<=18 years	1 2.1%
Between 18 and 65 years	45 93.8%
>=65 years	2 4.2%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42.5 (13.42)
Sex: Female, Male (Count of Participants)
Female	36 75%
Male	12 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	21 43.8%
White	24 50%
More than one race	0 0%
Unknown or Not Reported	2 4.2%
Region of Enrollment (participants) [Number]
United States	48 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Description	Percentage of subjects with treatment emergent adverse events (TEAEs)
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	48
Number [percentage of subjects]	66.7

2. Secondary Outcome

Title	Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Description	Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.
Time Frame	Baseline to12 Weeks

Outcome Measure Data

Analysis Population Description

Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	47
Mean (Standard Deviation) [units on a scale]	-5.9 (12.94)

3. Primary Outcome

Title	Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Description	Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	48
Number [percentage of subjects]	0

4. Primary Outcome

Title	Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Description	Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	48
Number [percentage of subjects]	4.2

5. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in CGI-S Score
Description	The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Time Frame	baseline to week 12

Outcome Measure Data

Analysis Population Description

Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	47
Mean (Standard Deviation) [units on a scale]	-0.47 (1.442)

6. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Description	The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	46
Mean (Standard Deviation) [units on a scale]	-1.5 (6.17)

7. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Description	The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	44
Mean (Standard Deviation) [units on a scale]	-1.5 (6.48)

8. Secondary Outcome

Title	Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Description	The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)

Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Measure Participants	36
Mean (Standard Deviation) [units on a scale]	-3.6 (9.95)

Adverse Events

Time Frame	12 Weeks
Arm/Group Title	Lurasidone 20, 40, 60 mg
Arm/Group Description	Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
All Cause Mortality
	Lurasidone 20, 40, 60 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lurasidone 20, 40, 60 mg
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Other (Not Including Serious) Adverse Events
	Lurasidone 20, 40, 60 mg
	Affected / at Risk (%)	# Events
Total	16/48 (33.3%)
Gastrointestinal disorders
Diarrhoea	4/48 (8.3%)	4
Nausea	3/48 (6.3%)	3
General disorders
Fatigue	3/48 (6.3%)	3
Infections and infestations
Upper respiratory tract infection	4/48 (8.3%)	4
Nervous system disorders
Akathisia	5/48 (10.4%)	6
Headache	3/48 (6.3%)	4
Sedation	3/48 (6.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed. 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 post completion of study at all sites, PI shall be free to publish.