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

A Phase 2 study testing Clozapine in people with Schizophrenia, run by Novartis.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: Clozapine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: No sites listed yet
Study dates: Apr 2001to Dec 2009
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Discontinued the core study
Pregnant or nursing (lactating) women
Other protocol-defined exclusion criteria may apply.

About this study

Official title: An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia

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.

Conditions: Schizophrenia
Being tested: Clozapine
Keywords: Schizophrenia, treatment-resistant, clozapine
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClozapineDrug
Also called Clozaril

Study groups in NCT00154258
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Clozapine

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events during the long term treatment (until NDA approval)
Measured: Baseline to 52 weeks
Vital signs at every 4 weeks
Measured: Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Measured: Baseline to 52 weeks
ECG at every 12 weeks
Measured: Baseline to 52 weeks
Echo cardiogram at every 24 weeks
Measured: 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
Measured: Baseline to 52 weeks
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Measured: Baseline to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2001Dec 2009

First posted12 Sep 2005 (estimated)
Study startApr 2001
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00154258
Sponsor's protocol ID: CLEX123J1202
Status last verified: Mar 2017
First submitted: 8 Sep 2005
Last updated: 24 Sep 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
ClinicalTrials.gov ID: NCT00154258
Acronym / sponsor ID: CLEX123J1202
Conditions: Schizophrenia
Keywords: Schizophrenia, treatment-resistant, clozapine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Apr 2001
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Clozapine

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

Discontinued the core study
Pregnant or nursing (lactating) women
Other protocol-defined exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClozapineAlso: Clozaril	Drug	1

Primary outcome

Adverse events during the long term treatment (until NDA approval)
Time frame: Baseline to 52 weeks
Vital signs at every 4 weeks
Time frame: Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Time frame: Baseline to 52 weeks
ECG at every 12 weeks
Time frame: Baseline to 52 weeks
Echo cardiogram at every 24 weeks
Time frame: Baseline to 52 weeks

2 secondary outcomes

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
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Time frame: Baseline to 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study chair

Novartis Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clozapine in people with Schizophrenia, run by Novartis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events during the long term treatment (until NDA approval) (time frame: Baseline to 52 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00154258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.