A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; Schizophrenia; MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2011-001711-31-SK
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1220

Inclusion Criteria

Screening and Open-label Stabilization Phase
1Subject is = 18 and = 75 years of age, on the day of signing the informed consent.
2.Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes as established by clinical interview (using the DSM-IV-TR as a reference and confirmed using the SCID-CT)]. The duration of the subject’s illness whether treated or untreated must be = 1 year.
3.Subject has had at least one prior episode of psychotic exacerbation as judged by the Investigator in the two years preceding screening.
4.Subject has a PANSS Total score = 80 with a score = 4 on 1 or more of any PANSS Positive subscale items at screening and open-label baseline (Visit 2).
5.Subject has a CGI-S score of = 4 at screening and open-label baseline (Visit 2).

Double-blind Phase
1. a PANSS Total score = 70 and a CGI-S score < 4 over at least 12 weeks with the allowance of two excursions (except during the last 4 weeks of the open-label phase) assessed at weekly study visits:
•An excursion is defined as a PANSS total score up to a maximum of 80 and CGI-S score up to a maximum of 4.
2. a PANSS item score of = 4 (moderate or less) on all Positive subscale items and item G8 (uncooperativeness)
3. taking a stable dose of lurasidone for the last 4 weeks of the open-label phase.

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 1098
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

Screening and Open-label Stabilization Phase
1.Subject has a DSM-IV Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
2.Subject answers yes” to Suicidal Ideation” item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment (at time of evaluation) at screening or baseline.
3.Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
4.Subject with Type 1 or Type 2 insulin-dependent diabetes.
5.Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
6.Subject has a prolactin concentration > 100 ng/mL at screening or has a history of pituitary adenoma.
7.Subject is judged to be resistant to antipsychotic treatment defined as any one of the following:
a.failure to respond to > 2 marketed antipsychotic agents, given at an adequate dose and for an adequate duration (within the past 2 years)
b.history of treatment with clozapine for refractory psychosis

Double-blind Phase
1.Subject who in the Investigator’s judgment have been non-compliant with study medication and/or study assessments during the open-label stabilization phase.

Study & Design

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