Safety and Tolerability Study of Drug to Treat Schizophrenia

A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone 20 mg; Drug: Lurasidone 40 mg; Drug: Lurasidone 80mg

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Birmingham Psychiatry Pharmaceutical
  • California
    • Cerritos, California, United States, 90703
      • Institute for Psychopharmacology Research
    • Garden Grove, California, United States, 92845
      • CNS Network
    • Glendale, California, United States, 91206
      • California Clinical Trials Medical Group
    • La Mesa, California, United States, 91942
      • Optimum Health Services
    • Orange, California, United States, 92868
      • University of California, Irvine
    • San Diego, California, United States, 92126
      • California Neuropsychopharmacology Clinical Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Psychiatric Institute of Washington
  • Florida
    • Melbourne, Florida, United States, 32935
      • Comprehensive Neuroscience. Inc.
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • Tampa, Florida, United States, 33613
      • University of South Florida
    • Winter Park, Florida, United States, 32789
      • Coordinated Research of Florida, Inc
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Hawaii Research Center
  • Illinois
    • Hoffman Estates, Illinois, United States, 60194
      • Alexian Brothers Behavioral Health Hospital
    • Oakbrook, Illinois, United States, 60523
      • American Medical Research
  • Nevada
    • North Las Vegas, Nevada, United States, 89030
      • Lake Mead Hospital
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Comprehensive Clinical Research, CNS
    • Kenilworth, New Jersey, United States, 07033
      • ClinSearch, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States, 19139
      • Quantum Clinical Services Group
  • Texas
    • Austin, Texas, United States, 78756
      • FutureSearch Trials
    • Austin, Texas, United States, 78756
      • Community Clinical Research
    • Bellaire, Texas, United States, 77401
      • Claghorn Lesem Research Clinic, Inc.
    • Dallas, Texas, United States, 75235
      • St. Paul Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22041
      • Cns, Inc.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • Medstream, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Successful completion of participation in protocol #D1050049

Exclusion criteria:

• Substance abuse
• Prolactin level of ≥200ng/mL at baseline
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lurasidone 20 mg; Lurasidone 20 mg oral tablet	Drug: Lurasidone 20 mg; Lurasidone 20mg oral tablet taken once daily for 6-months
Experimental: Lurasidione 40 mg; Lurasidone 40 mg oral tablet	Drug: Lurasidone 40 mg; Lurasidone 40mg oral tablets taken once daily
Experimental: Lurasidone 80mg; Lurasidone 80mg oral tablet	Drug: Lurasidone 80mg; Lurasidone 80mg oral tablet taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.	6-months

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): November 1, 2003
• Study Completion (Actual): November 1, 2003

Study Registration Dates

• First Submitted: August 16, 2002
• First Submitted That Met QC Criteria: August 19, 2002
• First Posted (Estimate): August 20, 2002

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Lurasidone; Latuda
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050174