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A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088634
Recruitment Status : Completed
First Posted : August 2, 2004
Results First Posted : March 1, 2011
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):

Brief Summary:
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone Drug: Placebo Phase 2

Detailed Description:
Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia
Study Start Date : May 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: Lurasidone
80 mg AM dosing once daily
Drug: Lurasidone
80 mg AM dosing once daily

Placebo Comparator: Placebo Drug: Placebo
Matching Placebo to 40mg lurasidone tablets

Primary Outcome Measures :
  1. Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score [ Time Frame: Baseline and 6 weeks ]
    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.

Secondary Outcome Measures :
  1. Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores [ Time Frame: Baseline and 6 weeks ]
    The PANSS 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.

  2. Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores [ Time Frame: Baseline and 6 weeks ]
    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).

  3. Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores [ Time Frame: Baseline and 6 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
  • The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
  • If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion Criteria:

  • The patient has used an investigational drug within the past 30 days
  • The patient has participated in a previous study of this compound

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088634

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Sponsors and Collaborators
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Study Director: Medical Director, MD Sunovion
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sunovion Identifier: NCT00088634    
Other Study ID Numbers: D1050196
First Posted: August 2, 2004    Key Record Dates
Results First Posted: March 1, 2011
Last Update Posted: April 8, 2016
Last Verified: March 2016
Keywords provided by Sunovion:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents