Phase 3 long-term safety, tolerability and effectiveness of lurasidone in subjects with schizophrenia or schizoaffective disorder

Phase 3

Completed

• Conditions: Mental and Behavioural Disorders; Schizophrenia

• Registration Number: ISRCTN97049967
• Lead Sponsor: Dainippon Sumitomo Pharma America Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Aged between 18 and 75 years, both genders
2. Meets the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for a primary diagnosis of schizophrenia
3. Judged by investigator to be clinically stable 8 weeks prior to baseline
4. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study
5. Tests negative for drug abuse at screening
6. Good physical health on the basis of medical history, physical examination and laboratory screening
7. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits
8. Provides written informed consent

Exclusion Criteria

1. Clinically significant medical condition that would pose a risk to subject in the study
2. Type 1 diabetes and insulin-dependent Type 2 diabetes
3. Chronic organic disease of the central nervous system
4. History of head injury resulting in attributable neuropsychiatric systems
5. History of malignancy <5 years prior to signing informed consent
6. Clinically significant history of alcohol abuse/alcoholism or drug abuse/dependence within last 6 months
7. History of macular or retinal pigmentary disease
8. History of stomach or intestinal surgery
9. History of previous psychosurgery
10. History of neuroleptic malignant syndrome
11. Severe tardive dyskinesia, severe chronic tardive dystonia or other severe chronic movement disorder
12. Clinically significant suicidal ideation, suicidal behaviour or violent behaviour in past 6 months.
13. Body mass index <18.5 or >40 kg/mg^2
14. Evidence of acute hepatitis, clinically significant chronic hepatitis or impaired hepatic function
15. Prolactin concentration >100 ng/mL at screening
16. Abnormal laboratory parameters indicating clinically significant medical condition
17. Resistant to antipsychotic treatment
18. Treatment with risperidone within 6 weeks prior to baseline
19. History of poor response to risperidone
20. Electroconvulsive therapy treatment within last 3 months or likely to require it during study
21. History of treatment with clozapine for refractory psychosis or clozapine treatment within 4 months of baseline visit
22. Treatment with mood stabilisers or antidepressants with 1 week, fluoxetine within 1 month
23. Received depot neuroleptics unless last injection at least 1 treatment cycle before randomisation
24. Subject does not require chronic treatment with antipsychotic drug
25. Subject has condition, therapy, laboratory abnormality which may affect results of/participation in study
26. History of hypersensitivity to risperidone
27. History or presence of abnormal electrocardiogram (ECG) which is clinically significant
28. Participation in study with investigational compound/device within 30 days of signing informed consent
29. Donation of blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent
30. Previously screened or entered into antipsychotic medication withdrawal phase of this study more than 3 times
31. Routinely use anabolic steroids or require ongoing treatment with steroids
32. Past or current Cushing's disease, Addison's disease, growth hormone deficiency, hyperparathyroidism
33. Unlikely to adhere to study procedures, in investigator's opinion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess long-term safety and tolerability of lurasidone by measuring proportion of subjects with adverse events and serious adverse events. These will be assessed at 12 months. Safety will also be assessed at 18 months.