A Phase 3 interventional study of Lurasidone in Bipolar I Disorder, sponsored by Sumitomo Pharma America, Inc.. Completed at 71 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-22.
Sponsored by Sumitomo Pharma America, Inc. · Phase 3, Interventional, and Treatment
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296
To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.
Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).
Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.
Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lurasidone 20, 40, 60,80 mg flexible dose
Drug: Lurasidone
Lurasidone 20-80 mg taken orally once daily
Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation
Time frame: 12 weeks
Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score
The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.
Time frame: baseline, 12 weeks (LOCF)
Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score
The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Time frame: baseline, 12 weeks (LOCF)
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)
Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time frame: Baseline, 12 weeks (LOCF)
Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression.
Time frame: baseline ,Week 12 (LOCF)
Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)
Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar 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, week 12 (LOCF)
Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score
The CGI-BP-S mania score is a single value, clinician-rated assessment of mania 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, week 12 (LOCF)
Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale
The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range 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, week 12 (LOCF)
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.
Time frame: baseline, week 12 (LOCF)
| Milestone | Lurasidone |
|---|---|
| Started | 377 |
| Completed | 338 |
| Not completed | 39 |
| Withdrew: Adverse event | 9 |
| Withdrew: Lack of efficacy | 8 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Protocol violation | 4 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Administration | 1 |
Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation
| participants | Lurasidone |
|---|---|
| at Least 1 TEAE potentially related to study drug | 155 |
| subjects with at least one TEAE potentially relate | 69 |
| at least 1 treatment emergent SAE | 14 |
| at least 1 treatment emergent SAE related to drug | 1 |
| at least 1 TEAE leading to discontinuation | 9 |
The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score | -1.0 ± 3.23 |
The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score | -0.2 ± 1.16 |
Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS) | -1.0 ± 5.17 |
Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS) | -1.9 ± 6.82 |
Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar 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.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) | -.31 ± 1.068 |
The CGI-BP-S mania score is a single value, clinician-rated assessment of mania 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
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score | -0.13 ± 0.807 |
The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale | -0.27 ± 0.969 |
The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.
| units on a scale | Lurasidone |
|---|---|
| Change From Baseline to Week 12 (LOCF) in the SDS Total Score | -1.4 ± 5.98 |
Collected over 12 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lurasidone | — | 14/377 (3.7%) | 51/377 (13.5%) |
| Event | Lurasidone |
|---|---|
| depressionPsychiatric disorders | 4/377 |
| maniaPsychiatric disorders | 2/377 |
| anaemia megaloblasticBlood and lymphatic system disorders | 1/377 |
| craniocerebral injuryInjury, poisoning and procedural complications | 1/377 |
| femur fractureInjury, poisoning and procedural complications | 1/377 |
| intentional overdoseInjury, poisoning and procedural complications | 1/377 |
| basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/377 |
| bipolar disorderPsychiatric disorders | 1/377 |
| emotional distressPsychiatric disorders | 1/377 |
| panic attackPsychiatric disorders | 1/377 |
| Event | Lurasidone |
|---|---|
| headacheNervous system disorders | 15/377 |
| nasopharyngitisInfections and infestations | 13/377 |
| akathisiaNervous system disorders | 12/377 |
| insomniaPsychiatric disorders | 11/377 |
| nauseaGastrointestinal disorders | 8/377 |
| Age, Categorical(Participants) | Lurasidone |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 359 |
| >=65 years | 17 |
| Age, Continuous(years) | Lurasidone |
|---|---|
| Mean | 45.5 ± 12.27 |
| Sex: Female, Male(Participants) | Lurasidone |
|---|---|
| Female | 206 |
| Male | 171 |
| Ethnicity (NIH/OMB)(Participants) | Lurasidone |
|---|---|
| Hispanic or Latino | 62 |
| Not Hispanic or Latino | 315 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Lurasidone |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 15 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 28 |
| White | 327 |
| More than one race | 0 |
| Unknown or Not Reported | 6 |
| Region of Enrollment(participants) | Lurasidone |
|---|---|
| Czech Republic | 40 |
| Russian Federation | 42 |
| Argentina | 30 |
| Hungary | 21 |
| United States | 95 |
| Japan | 13 |
| Poland | 37 |
| Slovakia | 5 |
| Bulgaria | 34 |
| France | 8 |
| Chile | 17 |
| Serbia | 35 |
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Sumitomo Pharma America, Inc.