A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone 20 mg; Drug: Lurasidone 40mg; Drug: Lurasidone 80 mg; Drug: Haloperidol 10mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 356
• 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, 92123
      • Sharp Mesa Vista Hospital
    • San Diego, California, United States, 92108
      • Affiliated Research Institute
    • San Diego, California, United States, 92126
      • California Neuropsychopharmacolgoy Clinical Research Insitute
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Comprehensive Neuroscience. Inc.
  • 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.
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Smyrna, Georgia, United States, 30080
      • Carman Research
  • 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
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Centers for Behavioral Health, LLC
  • Nevada
    • North Las Vegas, Nevada, United States, 89030
      • Lake Mead Hospital
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Comprehensive Clinical Research CNS, PC
    • Kenilworth, New Jersey, United States, 07033
      • ClinSearch, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Psychiatric Professional Services Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • Quantum Clinical Services Group
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center - Dept. of Psychiatry
  • 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
    • Dallas, Texas, United States, 75235
      • University Hills Clinical Research
  • Virginia
    • Falls Church, Virginia, United States, 22041
      • Cns, Inc.
  • Washington
    • Belleview, Washington, United States, 98004
      • Northwest Clinical Research Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • Medstream, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• The patient has a primary diagnosis of schizophrenia
• The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
• The patient has had a duration of illness of at least one year.
• The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
• The patient is able to remain off antipsychotic medication for a 4 day washout period

Exclusion criteria:

• The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
• The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lurasidone 20 mg; Lurasidone 20 mg tablets	Drug: Lurasidone 20 mg; Lurasidone 20mg/day tablets
Experimental: Lurasidone 40 mg; Lurasidone 40 mg tablets	Drug: Lurasidone 40mg; Lurasidone 40mg/day tablets
Experimental: Lurasidone 80 mg; Lurasidone 2 40 mg tablets	Drug: Lurasidone 80 mg; Lurasidone 80mg/day - 2 40mg tablets
Active Comparator: Haloperidol 10mg; Haloperidol 10mg tablets	Drug: Haloperidol 10mg; Haloperidol 10mg/day tablets
Placebo Comparator: Placebo; Matching Placebo to Lurasidone and Haloperidol	Drug: Placebo; Matching Placebo to Lurasdione and Haloperidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.	Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores	The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).	Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores	The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): May 1, 2003
• Study Completion (Actual): May 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; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; 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; Anti-Dyskinesia Agents; Adrenergic alpha-2 Receptor Antagonists; Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050049