Schizophrenia
Conditions
Keywords
Schizophrenia, Latuda, Lurasidone
Brief summary
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia
Detailed description
Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).
Interventions
DRUGLurasidone
80 mg AM dosing once daily
DRUGPlacebo
Matching Placebo to 40mg lurasidone tablets
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV * The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment * If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception
Exclusion criteria
* The patient has used an investigational drug within the past 30 days * The patient has participated in a previous study of this compound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score | Baseline and 6 weeks | The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores | Baseline and 6 weeks | The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia. |
| Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores | Baseline and 6 weeks | The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores | Baseline and 6 weeks | The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone 80 mg 2 40 mg lurasidone tablets taken once/day | 90 |
| Placebo Matching placebo to lurasidone 40 mg tablets taken once/day | 90 |
| Total | 180 |
Baseline characteristics
| Characteristic | Lurasidone 80 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 9.91 | 41.9 years STANDARD_DEVIATION 9.78 | 40.8 years STANDARD_DEVIATION 9.88 |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 68 Participants | 70 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 90 | 37 / 90 |
| serious Total, serious adverse events | 2 / 90 | 3 / 90 |
Outcome results
Primary
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score
The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.
Time frame: Baseline and 6 weeks
Population: Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone 80 mg | Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score | -8.9 units on a scale |
| Placebo | Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score | -4.2 units on a scale |
Comparison: Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.p-value: <0.05ANCOVA
Secondary
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline and 6 weeks
Population: Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone 80 mg | Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores | -0.6 units on a scale |
| Placebo | Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores | -0.2 units on a scale |
Comparison: Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.p-value: <0.05ANCOVA
Secondary
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Time frame: Baseline and 6 weeks
Population: Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone 80 mg | Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores | -2.9 units on scale |
| Placebo | Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores | -0.1 units on scale |
Comparison: Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.p-value: <0.05ANCOVA
Secondary
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Time frame: Baseline and 6 weeks
Population: Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone 80 mg | Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores | -14.1 units on a scale |
| Placebo | Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores | -5.5 units on a scale |
Comparison: Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.p-value: <0.05ANCOVA