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Completed

NCT Number: NCT00044044

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Psychiatry Pharmaceutical, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lurasidone 20 mg

Drug

Lurasidone 20mg/day tablets

Lurasidone 40mg

Drug

Lurasidone 40mg/day tablets

Lurasidone 80 mg

Drug

Lurasidone 80mg/day - 2 40mg tablets

Haloperidol 10mg

Drug

Haloperidol 10mg/day tablets

Placebo

Drug

Matching Placebo to Lurasdione and Haloperidol

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Aug 20, 2002
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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