Psychotic DisordersPhase 4PK-CLZNCT02286206
Study of the Effect of Dosing on Clozapine Levels
A Phase 4 study testing Clozapine in people with Psychotic Disorders and Schizophrenia, run by University of British Columbia at 1 site in Canada.
Trial summary
The objectives of this 15-day study are: 1. To compare steady-state trough plasma concentrations of clozapine and its metabolite norclozapine when given once daily and twice daily (at the same total daily dose) 2. To determine if frequency of clozapine administration has an effect on: 1. Symptoms of schizophrenia 2. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia
- What is being tested?
- Clozapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 4
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be between the ages of 19 - 65
- Participants must be fluent in English
- Participants must have a psychiatric diagnosis and are currently treated with clozapine once daily in the evening
- Participants must be on a stable dose of clozapine for at least one week to ensure steady-state has been achieved
Who cannot join
- Participants who are hypersensitive to clozapine
- Participants who are pregnant or lactating
- Participants who are of childbearing age and not using reliable contraception
- Participants who have postsurgical complications of the gastrointestinal tract that might impair absorption
- Participants who have any clinically relevant abnormalities of laboratory parameters
- Participants who have had a potent CYP1A2 metabolic inducer (e.g., carbamazepine; rifampin) or inhibitor (e.g., amiodarone; cimetidine; efavirenz; fluoroquinolone antibiotics; ticlopidine) added to and/or removed from their medication regimen in the past two weeks
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Hospital - Detwiller Pavilion
Vancouver, British Columbia, V6T 2A1
About this study
Official title: A Pilot Study to Determine How Frequency of Administration Modifies Steady-State Plasma Concentrations of Orally Administered Clozapine
The objectives of this 15-day study are:
- To compare steady-state trough plasma concentrations of clozapine and its metabolite norclozapine when given once daily and twice daily (at the same total daily dose)
- To determine if frequency of clozapine administration has an effect on:
- Symptoms of schizophrenia
- Adverse effects of clozapine
- Fasting blood glucose, lipids, creatinine, and urea
- Weight and waist circumference
Read the detailed description
It is important that clinicians do everything possible to optimize the use of clozapine in individuals with treatment-resistant schizophrenia. To our knowledge, there are no published studies evaluating whether twice daily administration of clozapine is better than once daily administration in terms of effectiveness and tolerability. Although this may seem trivial at first, when we consider that clozapine has a relatively short half-life and dissociates quickly from the dopamine D2 receptor, it justifies further consideration. It takes on even more significance knowing that the established threshold clozapine plasma concentration for therapeutic response (i.e., 350-420 ng/ml) was determined using steady-state trough plasma samples (i.e., approximately 12 hours after the evening dose) in patients administered clozapine twice rather than once daily.
- Conditions
- Psychotic Disorders, Schizophrenia
- Being tested
- Clozapine
- Keywords
- Clozapine, Psychotropic Drugs, Antipsychotic Agents, Psychotic Disorders, Schizophrenia, Adverse Effects, Drug Monitoring
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
Also called Clozaril, FazaClo
One-half baseline dose po bid (or one-third baseline dose po qam and two-thirds baseline dose po qhs at the discretion of the treating clinicians and principal investigator)
| Study group | Role | What they receive |
|---|---|---|
| Clozapine bid | Experimental | Participants have been taking clozapine once daily and have reached steady-state prior to the start of this study.
Intervention: Days 1-14 Receives: Drug: Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in steady-state trough plasma concentrations of clozapine and norclozapine at Days 7 and 14.
Steady-state trough plasma concentrations of clozapine and norclozapine will be measured on Days 7 and 14 and compared to those obtained on Day 0 (baseline).
Measured: Days 0 (baseline), 7, and 14
Secondary outcomes (4)
Change from baseline in symptoms at Day 14.
As assessed by structured clinical interviews for the Positive and Negative Syndrome Scale (PANSS)
Measured: Day 0 (baseline) and 14
Change from baseline in side effect burden at Day 14
As assessed by the Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Measured: Days 0 (baseline) and 14
Changes from baseline in laboratory measures at Day 14.
Laboratory measures include fasting blood glucose, fasting lipid profile, creatinine, and urea.
Measured: Days 0 (baseline) and 14
Change from baseline in weight and waist circumference at Day 14.
Measured: Days 0 (baseline) and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ric Procyshyn, University of British Columbia
- Investigators
- Ric M. Procyshyn, Ph.D, Principal investigator, University of British ColumbiaAlasdair Barr, Ph.D, Study director, University of British ColumbiaWilliam Honer, MD, Study director, University of British ColumbiaRandall White, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286206
- Sponsor's protocol ID
- H14-01644
- Acronym
- PK-CLZ
- Status last verified
- Oct 2021
- First submitted
- 4 Nov 2014
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine How Frequency of Administration Modifies Steady-State Plasma Concentrations of Orally Administered Clozapine
- ClinicalTrials.gov ID
- NCT02286206
- Acronym / sponsor ID
- PK-CLZ / H14-01644
- Conditions
- Psychotic Disorders, Schizophrenia
- Keywords
- Clozapine, Psychotropic Drugs, Antipsychotic Agents, Psychotic Disorders, Schizophrenia, Adverse Effects, Drug Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Nov 2014 (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.
The objectives of this 15-day study are:
- To compare steady-state trough plasma concentrations of clozapine and its metabolite norclozapine when given once daily and twice daily (at the same total daily dose)
- To determine if frequency of clozapine administration has an effect on:
- Symptoms of schizophrenia
- Adverse effects of clozapine
- Fasting blood glucose, lipids, creatinine, and urea
- Weight and waist circumference
Detailed description
It is important that clinicians do everything possible to optimize the use of clozapine in individuals with treatment-resistant schizophrenia. To our knowledge, there are no published studies evaluating whether twice daily administration of clozapine is better than once daily administration in terms of effectiveness and tolerability. Although this may seem trivial at first, when we consider that clozapine has a relatively short half-life and dissociates quickly from the dopamine D2 receptor, it justifies further consideration. It takes on even more significance knowing that the established threshold clozapine plasma concentration for therapeutic response (i.e., 350-420 ng/ml) was determined using steady-state trough plasma samples (i.e., approximately 12 hours after the evening dose) in patients administered clozapine twice rather than once daily.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clozapine bid | Experimental | Drug: ClozapineParticipants have been taking clozapine once daily and have reached steady-state prior to the start of this study. Intervention: Days 1-14 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be between the ages of 19 - 65
- Participants must be fluent in English
- Participants must have a psychiatric diagnosis and are currently treated with clozapine once daily in the evening
- Participants must be on a stable dose of clozapine for at least one week to ensure steady-state has been achieved
Key exclusion criteria (6 listed)
- Participants who are hypersensitive to clozapine
- Participants who are pregnant or lactating
- Participants who are of childbearing age and not using reliable contraception
- Participants who have postsurgical complications of the gastrointestinal tract that might impair absorption
- Participants who have any clinically relevant abnormalities of laboratory parameters
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, FazaCloOne-half baseline dose po bid (or one-third baseline dose po qam and two-thirds baseline dose po qhs at the discretion of the treating clinicians and principal investigator) | Drug | Clozapine bid |
Primary outcome
Change from baseline in steady-state trough plasma concentrations of clozapine and norclozapine at Days 7 and 14.
Time frame: Days 0 (baseline), 7, and 14
Steady-state trough plasma concentrations of clozapine and norclozapine will be measured on Days 7 and 14 and compared to those obtained on Day 0 (baseline).
4 secondary outcomes
Change from baseline in symptoms at Day 14.
Time frame: Day 0 (baseline) and 14
Change from baseline in side effect burden at Day 14
Time frame: Days 0 (baseline) and 14
Changes from baseline in laboratory measures at Day 14.
Time frame: Days 0 (baseline) and 14
Change from baseline in weight and waist circumference at Day 14.
Time frame: Days 0 (baseline) and 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Ric M. Procyshyn, Ph.D principal investigator
University of British Columbia
Alasdair Barr, Ph.D study director
University of British Columbia
William Honer, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clozapine in people with Psychotic Disorders and Schizophrenia, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in steady-state trough plasma concentrations of clozapine and norclozapine at Days 7 and 14. (time frame: Days 0 (baseline), 7, and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.