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A Comparison of Study Drug With Placebo and Haloperidol in Patients With 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: NCT00044044
Recruitment Status : Completed
First Posted : August 20, 2002
Results First Posted : April 12, 2011
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone 20 mg Drug: Lurasidone 40mg Drug: Lurasidone 80 mg Drug: Haloperidol 10mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2002
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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

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. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.

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 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.

  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:

  • 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

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): NCT00044044

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Sponsors and Collaborators
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Study Director: Medical Director, MD Sunovion

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Responsible Party: Sunovion Identifier: NCT00044044    
Other Study ID Numbers: D1050049
First Posted: August 20, 2002    Key Record Dates
Results First Posted: April 12, 2011
Last Update Posted: April 17, 2014
Last Verified: March 2014
Keywords provided by Sunovion:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol decanoate
Lurasidone Hydrochloride
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists