NCT00418873

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Mar 2007

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 16, 2010

Status Verified

April 1, 2010

Enrollment Period

2.8 years

First QC Date

January 3, 2007

Last Update Submit

April 15, 2010

Conditions

Schizophrenia

Keywords

schizophreniazotepinerisperidonesecond generation antipsychotic

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.

    6 Weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

1. Zotepine

EXPERIMENTAL
Drug: Zotepine

2. Risperidone

ACTIVE COMPARATOR
Drug: Risperidone

Interventions

ZotepineDRUG

Oral

Also known as: Lodopin®, Zoleptil®, Nipolept®
1. Zotepine
RisperidoneDRUG

Oral

Also known as: Risperdal®
2. Risperidone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Bali, Taipei, 249, Taiwan

Location

Unknown Facility

Taipei, 110, Taiwan

Location

Unknown Facility

Taipei, 114, Taiwan

Location

Unknown Facility

Taoyuan District, 330, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 24100785DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

zotepineRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chang-Jer Tsai

    Taipei City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 16, 2010

Record last verified: 2010-04

Locations

TW(4)