Schizophrenia
Conditions
Keywords
Schizophrenia, SM-13496, Latuda, Lurasidone
Brief summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.
Interventions
DRUGLurasidone
Lurasidone 80 mg tablets
DRUGQuetiapine XR
Quetiapine XR 600mg
DRUGPlacebo
Matching Placebo to Lurasidone or Quetiapine
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent and aged between 18 and 75 years of age. * Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia. * Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study. * Able and agrees to remain off prior antipsychotic medication for the duration of study. * Good physical health on the basis of medical history, physical examination, and laboratory screening. * Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion criteria
* Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. * Any chronic organic disease of the CNS (other than schizophrenia). * Used investigational compound within 30 days. * Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | Week 6 | The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment | 6-Weeks | Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). |
Countries
India, Romania, Russia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone 80 mg Lurasidone 80 mg tablets taken orally once a day | 125 |
| Lurasidone 160 mg Lurasidone 160 mg (4 tablets) taken orally once a day | 121 |
| Quetiapine XR 600mg Quetiapine XR 600 mg (4 tablets) orally taken once a day | 120 |
| Placebo Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%. | 122 |
| Total | 488 |
Baseline characteristics
| Characteristic | Lurasidone 80 mg | Lurasidone 160 mg | Quetiapine XR 600mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 10.9 | 37.9 years STANDARD_DEVIATION 11.3 | 37.4 years STANDARD_DEVIATION 10.4 | 37.4 years STANDARD_DEVIATION 10.8 | 37.2 years STANDARD_DEVIATION 10.8 |
| Gender Female | 29 participants | 39 participants | 42 participants | 44 participants | 154 participants |
| Gender Male | 96 participants | 82 participants | 77 participants | 77 participants | 332 participants |
| Region of Enrollment Colombia | 7 participants | 6 participants | 6 participants | 7 participants | 26 participants |
| Region of Enrollment India | 24 participants | 25 participants | 25 participants | 24 participants | 98 participants |
| Region of Enrollment Romania | 13 participants | 11 participants | 13 participants | 12 participants | 49 participants |
| Region of Enrollment Russian Federation | 22 participants | 22 participants | 21 participants | 22 participants | 87 participants |
| Region of Enrollment Ukraine | 19 participants | 20 participants | 19 participants | 17 participants | 75 participants |
| Region of Enrollment United States | 40 participants | 37 participants | 35 participants | 39 participants | 151 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 71 / 125 | 76 / 121 | 70 / 119 | 69 / 121 |
| serious Total, serious adverse events | 1 / 125 | 4 / 121 | 1 / 119 | 4 / 121 |
Outcome results
Primary
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time frame: Week 6
Population: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone 80 mg | Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | -22.2 scores on a scale |
| Lurasidone 160 mg | Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | -26.5 scores on a scale |
| Quetiapine XR 600mg | Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | -27.8 scores on a scale |
| Placebo | Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | -10.3 scores on a scale |
p-value: <0.05Mixed Models Analysis
Secondary
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Time frame: 6-Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone 80 mg | Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment | -1.5 scores on a scale |
| Lurasidone 160 mg | Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment | -1.7 scores on a scale |
| Quetiapine XR 600mg | Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment | -1.7 scores on a scale |
| Placebo | Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment | -0.9 scores on a scale |
p-value: <0.05Mixed Models Analysis