A 6-Week Study looking at the effectiveness and Safety of Lurasidone in Acutely Psychotic Subjects with Schizophrenia

Phase 1

• Conditions: Schizophrenia; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-000060-42-PL
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-22
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

1. Subject must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study-related activities. If the subject is considered a minor per local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
2. Subject is = 18 and = 74 years of age, on the day of signing the informed consent.
3. Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), or undifferentiated (295.90) subtypes] as established by clinical interview using the MINI 6.0 diagnostic interview with DSM-IV-TR criteria. Note: The diagnosis of schizophrenia and appropriateness of inclusion in the study will be independently confirmed by external review.
4. Subject has a PANSS total score = 80 and a PANSS subscale score = 4 (moderate) on 2 or more of the following PANSS subscale items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), or unusual thought content (G9) at Screening and Baseline.
5. Subject must have a score of 4 (moderately ill) or higher on the CGI-S at Screening and Baseline.
6. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months [60 days] prior to the Screening visit) and marked deterioration of function from baseline (by history). Subject must present with exacerbation of mainly positive symptoms (e.g, exacerbation of delusion or hallucination, thought disorder).
7. Subject must be able to be hospitalized from Visit 2 (Washout) through Visit 5 (Week 2) assessments.
8. Female subjects must not be pregnant (must have a negative serum pregnancy test at Screening) or nursing (must not be lactating) and not planning to become pregnant within the projected duration of the study.
9. Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 452
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Subjects with an acute exacerbation of psychotic symptoms > 2 months (60 days) are not eligible for this study.
2. Subjects who have been continuously hospitalized for > 3 months (90 days) immediately prior to screening are not eligible for this study.
3. Subjects who have been continuously hospitalized for = 14 days for acute exacerbation of psychotic symptoms immediately prior to Screening are eligible for this study.
4. Subject has a DSM-IV Axis I or Axis II diagnosis, other than schizophrenia, that has been the primary focus of treatment within 1 year (365 days) of Screening.
5. Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or answers yes” to Suicidal Ideation” item 4 or item 5 on the C-SSRS assessment at the Screening visit (in the past month [30 days]) or Baseline.
6. Subject has a prolactin concentration > 100 ng/mL at Screening or has a history of pituitary adenoma.
7. Subject has previous or existing serious cardiovascular, renal, organic brain, hematologic, endocrine, convulsive disease, or other serious medical conditions, or is considered ineligible for the study by the Investigator for any reason.
8. Subject has a history of treatment with clozapine for refractory psychosis or treatment resistant schizophrenia.
9. Subject is receiving a total dose of antipsychotic medication equivalent to = 12.0 mg/day of haloperidol at the Screening visit.
10. Subject requires treatment with any medications that are potent cytochrome P450 (CYP) 3A4 inhibitors or inducers for the period of 14 days prior to Baseline through the end of the study.
11. Subject demonstrates a decrease (improvement) of = 20% in the PANSS total score between Screening and Baseline visits, or the PANSS total score falls below 80 at Baseline.
12. Subject is considered resistant to antipsychotic treatment by the Investigator, defined as per the protocol
13. Subject has received any depot antipsychotic drugs (sustained-release formulation) more recently than the minimum required washout prior to the Screening visit.
14. Subject received fluoxetine within 1 month (30 days) or monoamine oxidase (MAO) inhibitors within 21 days prior to the Screening visit.
15. Subject underwent electroconvulsive therapy within 6 months (180 days) prior to the Screening visit.
16. Subject has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
17. Subject has any abnormal laboratory parameter at Screening that indicates a clinically significant medical condition as determined by the Investigator.
18. Subjects with type 1 diabetes, or insulin-dependent diabetics are excluded. Subjects with type 2 diabetes subjects are eligible if the protocol-specified conditions are met.
19. Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
20. Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
21. Subject has evidence of any chronic organic disease of the central nervous system (CNS). In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury.
22. Subject has any gastrointestinal disorder or co

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified