Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Lurasidone, Schizophrenia, Latuda
Brief summary
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
Interventions
DRUGLurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject ≥ 18 years of age. * Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder. * Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
Exclusion criteria
* Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening. * Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening. * Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse of Psychotic Symptoms During 6 Weeks | 6 Weeks | Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability and Safety | 6 Weeks | Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events |
Countries
United States
Participant flow
Recruitment details
FPI June 24, 2010-LPV May 19, 2011, locations were private health clinics, university hospitals, private research facilities.
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone Open-Label Arm 40/40 Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg | 72 |
| Lurasidone Open-Label Arm 40/80 Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily | 87 |
| Lurasidone Open-Label Arm 80/80 Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks | 81 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative | 1 | 0 | 0 |
| Overall Study | Adverse Event | 5 | 6 | 5 |
| Overall Study | Lack of Efficacy | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 | 4 |
| Overall Study | Non-compliance with study drug | 0 | 1 | 1 |
| Overall Study | Principal Investigator Decision | 2 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | Lurasidone Open-Label Arm 40/80 | Lurasidone Open-Label Arm 80/80 | Lurasidone Open-Label Arm 40/40 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 81 Participants | 71 Participants | 237 Participants |
| Age Continuous | 44.0 years STANDARD_DEVIATION 11.5 | 44.4 years STANDARD_DEVIATION 10 | 43.2 years STANDARD_DEVIATION 11.3 | 43.9 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 87 participants | 81 participants | 72 participants | 240 participants |
| Sex: Female, Male Female | 37 Participants | 22 Participants | 25 Participants | 84 Participants |
| Sex: Female, Male Male | 50 Participants | 59 Participants | 47 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 72 | 62 / 87 | 59 / 81 |
| serious Total, serious adverse events | 3 / 72 | 2 / 87 | 0 / 81 |
Outcome results
Primary
Time to Relapse of Psychotic Symptoms During 6 Weeks
Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event
Time frame: 6 Weeks
Population: Intend to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone Open-Label Arm 40/40 | Time to Relapse of Psychotic Symptoms During 6 Weeks | 23.8 days | Standard Deviation 12.1 |
| Lurasidone Open-Label Arm 40/80 | Time to Relapse of Psychotic Symptoms During 6 Weeks | 16.9 days | Standard Deviation 11.6 |
| Lurasidone Open-Label Arm 80/80 | Time to Relapse of Psychotic Symptoms During 6 Weeks | 17.3 days | Standard Deviation 8.9 |
Secondary
Tolerability and Safety
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: 6 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone Open-Label Arm 40/40 | Tolerability and Safety | 72 participants |
| Lurasidone Open-Label Arm 40/80 | Tolerability and Safety | 87 participants |
| Lurasidone Open-Label Arm 80/80 | Tolerability and Safety | 81 participants |