CClinicalTrials.gg
CompletedNCT00154258Updated Sep 24, 2020

A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia

A Phase 2 interventional study of Clozapine in Schizophrenia, sponsored by Novartis. Completed. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-09-24.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia, treatment-resistant, clozapine
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 19 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Other protocol-defined exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    1

    Drug: Clozapine

Interventions

  • DrugClozapine

    Also known as: Clozaril

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to 52 weeks

  2. Vital signs at every 4 weeks

    Time frame: Baseline to 52 weeks

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

    Time frame: Baseline to 52 weeks

  4. ECG at every 12 weeks

    Time frame: Baseline to 52 weeks

  5. Echo cardiogram at every 24 weeks

    Time frame: Baseline to 52 weeks

Secondary outcomes

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

    Time frame: Baseline to 52 weeks

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

    Time frame: Baseline to 52 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00154258
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Apr 2001
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Sep 24, 2020

Study contacts

Novartis Pharmaceuticals
study chair · Novartis Pharmaceuticals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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