Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00549718
First received: October 24, 2007
Last updated: June 5, 2014
Last verified: June 2014

October 24, 2007
June 5, 2014
October 2007
October 2010   (final data collection date for primary outcome measure)
Change in Total PANSS Score From Baseline to the End of the Double Blind Phase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Change in total PANSS score from baseline to the end of the double blind phase [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00549718 on ClinicalTrials.gov Archive Site
CGI-S From Baseline to the End of the Double-blind Treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
CGI-S from baseline to the end of the double-blind treatment [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
Drug: Lurasidone HCl
Once daily
  • Experimental: Lurasidone 40mg
    Intervention: Drug: Lurasidone HCl
  • Experimental: Lurasidone 80mg
    Intervention: Drug: Lurasidone HCl
  • Experimental: Lurasidone 120mg
    Intervention: Drug: Lurasidone HCl
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Lurasidone HCl
Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: A 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17. PubMed PMID: 23421963.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

  • Provide written informed consent and aged between 18 and 75 years of age.
  • Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
  • Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

  • Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Any chronic organic disease of the CNS (other than schizophrenia)
  • Used investigational compound within 30 days.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   India,   Malaysia,   Romania,   Russian Federation,   Ukraine
 
NCT00549718
D1050229, 2007-003819-31
Yes
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP