A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia - Full Text View

Sponsor:	Sunovion
Information provided by (Responsible Party):	Sunovion
ClinicalTrials.gov Identifier:	NCT00044044

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Lurasidone 20 mg Drug: Lurasidone 40mg Drug: Lurasidone 80 mg Drug: Haloperidol 10mg Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Lurasidone SM-13496

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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).
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	356
Study Start Date:	July 2002
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044044

Show 34 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

Medical Director, MD

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00044044 History of Changes
Other Study ID Numbers:	D1050049
Study First Received:	August 16, 2002
Results First Received:	February 1, 2011
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Schizophrenia
Latuda
Lurasidone

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
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

ClinicalTrials.gov processed this record on February 12, 2012