NCT00154258

Brief Summary

Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_2 schizophrenia

Status
completed

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

Study Start

First participant enrolled

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.2 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

September 24, 2020

Status Verified

March 1, 2017

Enrollment Period

8.7 years

First QC Date

September 8, 2005

Last Update Submit

September 22, 2020

Conditions

Schizophrenia

Keywords

Schizophrenia, treatment-resistant, clozapine

Outcome Measures

Primary Outcomes (5)

  • Adverse events during the long term treatment (until NDA approval)

    Baseline to 52 weeks

  • Vital signs at every 4 weeks

    Baseline to 52 weeks

  • Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)

    Baseline to 52 weeks

  • ECG at every 12 weeks

    Baseline to 52 weeks

  • Echo cardiogram at every 24 weeks

    Baseline to 52 weeks

Secondary Outcomes (2)

  • Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

    Baseline to 52 weeks

  • Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

    Baseline to 52 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Clozapine

Interventions

ClozapineDRUG
Also known as: Clozaril
1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Attended the previous Phase IIb (core) study
  • Improved during the core study
  • No safety issues during the core study

You may not qualify if:

  • Discontinued the core study
  • Pregnant or nursing (lactating) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2001

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 24, 2020

Record last verified: 2017-03