Zotepine Versus Risperidone in Aggressive Schizophrenic P... | NCT00418873

Studies
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

NCT00418873

Sponsor

Astellas Pharma Inc

Status

Terminated

Last Update Posted

Apr 16, 2010Estimated

Enrollment

39Actual

Phase

Phase 4

Conditions

Schizophrenia

Interventions

Zotepine
Risperidone

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due to difficulty in patient enrollment

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jan 3, 2007

First Submission Date that Met QC Criteria

Jan 4, 2007

First Posted Date

Jan 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2010

Last Update Posted Date

Apr 16, 2010Estimated

Name	Class
Astellas Pharma Taiwan, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. Zotepine	Experimental		Drug: Zotepine
2. Risperidone	Active Comparator		Drug: Risperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zotepine	Drug	Oral	1. Zotepine	Lodopin® Zoleptil®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.		6 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline on the total score of Positive and Negative Syndrome Scale		6 Weeks
Change from baseline on Clinical Global Impression (CGI)		6 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 to 65 years, male or female
In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.
Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4

Exclusion Criteria:

Patients with history of seizure or with alcohol or substance abuse in the last 6 months
Diabetes, Parkinson's disease or phaeochromocytoma
Patients with hypertension and current use of antihypertensive agents
Women who are pregnant, lactating or intend to become pregnant during the study period
Poor response to two different antipsychotics in full dose and full course or use of clozapine previously
Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Chang-Jer Tsai	Taipei City Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24100785	Derived	Chan HY, Lin AS, Chen KP, Cheng JS, Chen YY, Tsai CJ. An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation. J Clin Psychopharmacol. 2013 Dec;33(6):747-52. doi: 10.1097/JCP.0b013e31829e8168.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Facility	Status	City	State	ZIP	Country	Contacts
		Bali	Taipei	249	Taiwan