Schizophrenia Spectrum and Other Psychotic DisordersCLOZINNCT03253367
Phenomics and Genomics of Clozapine Pharmacotherapy
An observational study of Schizophrenia Spectrum and Other Psychotic Disorders, run by Jurjen Luykx at 11 sites in 4 countries.
Trial summary
A burgeoning body of research has pointed to increased efficacy of clozapine (CLZ) over other antipsychotics in schizophrenia (SCZ). On the other hand, safety concerns likely cause underutilization across a range of European and other nations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Blood is obtained, mostly during routine venipuncture
- How many people
- 2,500 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 19 Jan 2016to Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will include 2,500 patients diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS (together referred to as SCZ) >18 years of age who are currently on CLZ treatment or have used CLZ in the past. Publicly available Psychiatric Genomics Consortium (PGC) GWAS data will be used for comparisons with the broad schizophrenia phenotype group. For the purpose of the case-control comparison, the 2,500 subjects who use or have used CLZ will be age and sex-matched to 13,000 healthy control subjects for whom genotype data are available in-house.
Who may be able to join
- he/she currently uses CLZ or he/she has used CLZ in the past/will use CLZ
- he/she has received a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS.
- his/her age must be ≥18 years old
- he/she must be able to speak and read the language of the Informed Consent (differs per country)
- he/she must be mentally competent and have decisional capacity with regard to a decision to participate in the current study
Who cannot join
- admission to a psychiatric unit involuntarily (not all countries)
- a history of Parkinson's disease
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Netherlands7 sites, 3 recruiting
- Recruiting
Reinier van Arkel
's-Hertogenbosch, North Brabant, 5211 LJ
Koen Grootens, MD
- Terminated
Yulius
Barendrecht, South Holland, 2994 GC
- Terminated
GGZ-NHN
Heerhugowaard, North Holland, 1703 WC
- Enrolling by invitation
GGZ Rivierduinen
Leiden, Oegstgeest, 2342 EJ
- Recruiting
UMC Utrecht
Utrecht, 3508 GA
Marte van der Horst, Drs., 0887551460 ext. +31, c.pfeifer@umcutrecht.nl
- Terminated
Altrecht
Utrecht, 3512 PK
- Withdrawn
Vincent van Gogh Institute
Venray, Limburg, 5803 AC
Germany2 sites, 2 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 10117
Stefanie Schreiter, MD, 004930450517009, stefanie.schreiter@charite.de
Stefan Gutwinski, MD, 004930450517009, stefan.gutwinski@charite.de
- Recruiting
LMU Munich
München, Munich, 80336
Alkomiet Hasan, MD, PhD
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, 6020
Monika Edlinger, MD, monika.edlinger@i-med.ac.at
Finland1 site, 1 recruiting
- Recruiting
Niuvanniemen hospital
Kuopio, 70240
Jari Tiihonen, Prof.
About this study
Official title: Phenomics and Genomics in Clozapine Pharmacotherapy: Current, Former and New Clozapine Users
A burgeoning body of research has pointed to increased efficacy of clozapine (CLZ) over other antipsychotics in schizophrenia (SCZ). On the other hand, safety concerns likely cause underutilization across a range of European and other nations. The lack of data available to predict efficacy and adverse drug reactions (ADRs) of CLZ further contributes to underprescription rates in these countries. Here, we hypothesize that (epi)genetic and non-genetic factors aid to help predict treatment outcome (efficacy + ADRs) to CLZ. We furthermore posit that such prediction will result in enhanced quality of life of both patients and family members. Our primary objective is to predict CLZ treatment outcome based on phenotypic and genetic data obtained through the current design. The first secondary objective is to investigate which methylation levels/patterns are correlated with CLZ treatment outcome. The second secondary objective is to aid in the further elucidation of the genetic architecture of SCZ and any possible differences between 'regular' SCZ patients and those on CLZ, who are generally more severely ill. We thus intend to cover two currently unmet needs using a precision medicine approach: the lack of knowledge about determinants of treatment response to CLZ and the lack of insight into neurobiological differences between 'regular' SCZ and relatively treatment resistant subjects (CLZ users). The prime analysis will be a common variant hypothesis-generating genotyping endeavor investigating treatment response to CLZ. Additional analyses include whole-genome methylation and gene expression analyses and analyses of non-genetic determinants of response. We will include 2,500 CLZ treated patients for our discovery cohort, which is in line with previous whole-genome pharmacogenomics studies and our power calculations. We will replicate any genome-wide loci using our prospectively collected cohort of new users (N=59). Potential yields include a publicly available prediction tool to help identify patients responsive to CLZ in early disease stages and prevent harmful effects. In addition, common variant analyses compounded by pathway analyses may help elucidate the mechanisms of action of CLZ. We ask for broad informed consent from participants ensuring rich, longitudinal phenotypic and genotypic data resources for both currently planned and future analyses, allowing e.g. next-generation sequencing focused on both CLZ and SCZ disease genetics (e.g. in large consortia). We plan to also generate polygenic risk scores (PRS) of CLZ efficacy and use those to identify other diseases or patients for which CLZ may be helpful, e.g. schizoaffective disorder patients who are sometimes first treated with mood stabilizers. Last, evidence hints that disparaging genetic loci influence efficacy to different antipsychotics. Adding genetic data from our cohort to existing datasets of response to other antipsychotics may help identify such loci. Finally, comparison studies with non-CLZ using patients suffering from SCZ may deepen the understanding of biological mechanisms underlying treatment resistance (or: a relatively severe course of illness).The results of this genetic part of the study will be combined with the results from our other research protocol 'Phenomics and genomic of clozapine pharmacotherapy - New Users'.The overarching goal of both projects is to create a prediction model for clozapine outcome (response (and side effects). This model includes genetic, epigenetic and clinical data.
Read the detailed description
Rationale Clozapine (CLZ) is generally prescribed if at least two trials of antipsychotic agents have not led to satisfactory clinical improvement, thereby implying that patients on CLZ generally suffer from more severe and/or persistent symptoms than patients suffering from schizophrenia spectrum disorders (SCZ) on other antipsychotic agents. Unraveling the (functional) genetic variation underlying this severe SCZ phenotype therefore has the potential to deepen our understanding of the biological underpinnings of SCZ beyond the boundaries of DSM-based consensus criteria. Such knowledge in turn has the potential to shape future pharmacotherapeutic research. The investigators here hypothesize that targeting this phenotype in genome-wide association studies and next-generation sequencing studies will signal genetic risk loci implicated in this severe SCZ phenotype. In the future, this may lead to early detection of severe SCZ, which in turn will enable tailoring of pharmacotherapeutic strategies to such SCZ subtypes. The results of this genetic part of the study will be combined with the results from our other research protocol ('Phenomics and genomic of clozapine pharmacotherapy - New Users').The overarching goal of both projects is to create a prediction model for clozapine outcome (response (and side effects). This model includes genetic, epigenetic and clinical data.
Objectives
Primary:
- To predict CLZ efficacy and ADRs (=treatment outcome) based on phenotypic and genetic data obtained in this study.
Secondary:
- To investigate which non-genetic factors, methylation and gene expression levels/patterns predict treatment outcome after initiating CLZ;
- As the genetic architecture of SCZ has not been fully elucidated, the current project will aid in the further elucidation of the genetic architecture of SCZ and any possible differences between 'regular' SCZ patients (those not considered treatment resistant) and those on CLZ (considered generally to be a more homogeneous and severe group).
Study design This is a mostly cross-sectional study, in which both phenotypic and genotypic data are gathered from this study population that currently uses CLZ or has used CLZ in the past. A genome-wide association study (GWAS) will be performed to reveal possible differences in genetic architecture between patients who use or have used CLZ and the broad schizophrenia phenotype on the one hand and between those who use or have used CLZ and healthy controls on the other. Targeted next-generation sequencing may be used to follow-up possible positive associations. The genetic data will be used to analyse which genetic variants are associated with CLZ response and/or side effects.
Study population The investigators will include 2,500 patients diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS (together referred to as SCZ) >18 years of age who are currently on CLZ treatment or have used CLZ in the past. Publicly available Psychiatric Genomics Consortium (PGC) GWAS data will be used for comparisons with the broad schizophrenia phenotype group. For the purpose of the case-control comparison, the 2,500 subjects who use or have used CLZ will be age and sex-matched to 30,000 healthy control subjects for whom genotype data are available in-house.
Intervention No intervention will be applied.
Main study parameters/endpoints
- To assess whether the genetic architecture of this severe SCZ phenotype differs from the broad DSM-based SCZ phenotype.
- To predict clozapine response and side effects based on phenotypic and genetic data obtained in this study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Almost all patients on CLZ regularly have their blood drawn for routine white blood cell counts and/or CLZ blood level assessments. The investigators anticipate that the majority of the study population will consist of such patients as white blood cell monitoring is strictly enforced in clinical practice for this patient group. For these patients, no additional risks will be attached to the study, as the blood necessary for DNA extraction for the current study will be drawn during these routinely performed venipunctures. Time investment will also be low as the patients will only undergo a 10-minute interview. A minority of patients on CLZ does not have their blood routinely monitored and neither do patients who have used CLZ in the past. These subjects will be asked to allow a single blood draw. A venipuncture entails the risk of a hematoma (blood leaving the vessel). The investigators aim to minimize this risk by only allowing experienced personnel to draw blood and in the event of deeply located or thin veins request central lab personnel to perform the venipuncture. Although a hematoma resulting from a traumatic puncture imposes an esthetical burden on the subject, no serious health risks are involved.
- Being tested
- Blood is obtained, mostly during routine venipuncture
- Keywords
- Schizophrenia Spectrum and Other Psychotic Disorders
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood is obtained, mostly during routine venipunctureOther
| Study group | Role | What they receive |
|---|---|---|
| Current/former clozapine users | This group has only one visit. Receives: Other: Blood is obtained, mostly during routine venipuncture | |
| New clozapine users | This group will be followed for 6 months prospectively. Receives: Other: Blood is obtained, mostly during routine venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict clozapine response.
To predict clozapine response based on phenotypic information from our questionnaire (CGI + CRES) and genetic information from GWAS
Measured: 2016-2021
Predict side effects from clozapine use
To predict clozapine response based on phenotypic information from our questionnaire (LUNSERS) and genetic information from GWAS
Measured: 2016-2021
Assess differences in genetic architecture (GWAS)
To assess whether the genetic architecture of this severe SCZ phenotype differs from the broad DSM-based SCZ phenotype. this will be done by comparing the gentic material of clozapine users vs. non-clozapine users. Only the clozapine DNA has to be collected yet.
Measured: 2016-2021
Secondary outcomes (2)
Detect genetic associations (GWAS) Detect genetic associations current severe SCZ phenotype
To detect genetic associations with the current severe SCZ phenotype by performing a case-control comparison with healthy participants (GWAS).
Measured: 2016-2021
Increase or decrease cardiovascular disease?
To investigate whether CLZ use increases or decreases the risk of cardiovascular disease and early death. This is done by following the patients for 10 years and see whether they developed serious cardiovascular diseases
Measured: 2016-2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start19 Jan 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jurjen Luykx
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jurjen Luykx, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253367
- Sponsor's protocol ID
- ABR: 52726 & 52728
- Acronym
- CLOZIN
- Status last verified
- Mar 2020
- First submitted
- 29 May 2017
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data can be shared with other investigators when the sponsor agreed on the workpackage of that investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomics and Genomics in Clozapine Pharmacotherapy: Current, Former and New Clozapine Users
- ClinicalTrials.gov ID
- NCT03253367
- Acronym / sponsor ID
- CLOZIN / ABR: 52726 & 52728
- Keywords
- Schizophrenia Spectrum and Other Psychotic Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Jurjen LuykxUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Aug 2017 (actual)
- 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.
A burgeoning body of research has pointed to increased efficacy of clozapine (CLZ) over other antipsychotics in schizophrenia (SCZ). On the other hand, safety concerns likely cause underutilization across a range of European and other nations. The lack of data available to predict efficacy and adverse drug reactions (ADRs) of CLZ further contributes to underprescription rates in these countries. Here, we hypothesize that (epi)genetic and non-genetic factors aid to help predict treatment outcome (efficacy + ADRs) to CLZ. We furthermore posit that such prediction will result in enhanced quality of life of both patients and family members. Our primary objective is to predict CLZ treatment outcome based on phenotypic and genetic data obtained through the current design. The first secondary objective is to investigate which methylation levels/patterns are correlated with CLZ treatment outcome. The second secondary objective is to aid in the further elucidation of the genetic architecture of SCZ and any possible differences between 'regular' SCZ patients and those on CLZ, who are generally more severely ill. We thus intend to cover two currently unmet needs using a precision medicine approach: the lack of knowledge about determinants of treatment response to CLZ and the lack of insight into neurobiological differences between 'regular' SCZ and relatively treatment resistant subjects (CLZ users). The prime analysis will be a common variant hypothesis-generating genotyping endeavor investigating treatment response to CLZ. Additional analyses include whole-genome methylation and gene expression analyses and analyses of non-genetic determinants of response. We will include 2,500 CLZ treated patients for our discovery cohort, which is in line with previous whole-genome pharmacogenomics studies and our power calculations. We will replicate any genome-wide loci using our prospectively collected cohort of new users (N=59). Potential yields include a publicly available prediction tool to help identify patients responsive to CLZ in early disease stages and prevent harmful effects. In addition, common variant analyses compounded by pathway analyses may help elucidate the mechanisms of action of CLZ. We ask for broad informed consent from participants ensuring rich, longitudinal phenotypic and genotypic data resources for both currently planned and future analyses, allowing e.g. next-generation sequencing focused on both CLZ and SCZ disease genetics (e.g. in large consortia). We plan to also generate polygenic risk scores (PRS) of CLZ efficacy and use those to identify other diseases or patients for which CLZ may be helpful, e.g. schizoaffective disorder patients who are sometimes first treated with mood stabilizers. Last, evidence hints that disparaging genetic loci influence efficacy to different antipsychotics. Adding genetic data from our cohort to existing datasets of response to other antipsychotics may help identify such loci. Finally, comparison studies with non-CLZ using patients suffering from SCZ may deepen the understanding of biological mechanisms underlying treatment resistance (or: a relatively severe course of illness).The results of this genetic part of the study will be combined with the results from our other research protocol 'Phenomics and genomic of clozapine pharmacotherapy - New Users'.The overarching goal of both projects is to create a prediction model for clozapine outcome (response (and side effects). This model includes genetic, epigenetic and clinical data.
Detailed description
Rationale Clozapine (CLZ) is generally prescribed if at least two trials of antipsychotic agents have not led to satisfactory clinical improvement, thereby implying that patients on CLZ generally suffer from more severe and/or persistent symptoms than patients suffering from schizophrenia spectrum disorders (SCZ) on other antipsychotic agents. Unraveling the (functional) genetic variation underlying this severe SCZ phenotype therefore has the potential to deepen our understanding of the biological underpinnings of SCZ beyond the boundaries of DSM-based consensus criteria. Such knowledge in turn has the potential to shape future pharmacotherapeutic research. The investigators here hypothesize that targeting this phenotype in genome-wide association studies and next-generation sequencing studies will signal genetic risk loci implicated in this severe SCZ phenotype. In the future, this may lead to early detection of severe SCZ, which in turn will enable tailoring of pharmacotherapeutic strategies to such SCZ subtypes. The results of this genetic part of the study will be combined with the results from our other research protocol ('Phenomics and genomic of clozapine pharmacotherapy - New Users').The overarching goal of both projects is to create a prediction model for clozapine outcome (response (and side effects). This model includes genetic, epigenetic and clinical data.
Objectives
Primary:
- To predict CLZ efficacy and ADRs (=treatment outcome) based on phenotypic and genetic data obtained in this study.
Secondary:
- To investigate which non-genetic factors, methylation and gene expression levels/patterns predict treatment outcome after initiating CLZ;
- As the genetic architecture of SCZ has not been fully elucidated, the current project will aid in the further elucidation of the genetic architecture of SCZ and any possible differences between 'regular' SCZ patients (those not considered treatment resistant) and those on CLZ (considered generally to be a more homogeneous and severe group).
Study design This is a mostly cross-sectional study, in which both phenotypic and genotypic data are gathered from this study population that currently uses CLZ or has used CLZ in the past. A genome-wide association study (GWAS) will be performed to reveal possible differences in genetic architecture between patients who use or have used CLZ and the broad schizophrenia phenotype on the one hand and between those who use or have used CLZ and healthy controls on the other. Targeted next-generation sequencing may be used to follow-up possible positive associations. The genetic data will be used to analyse which genetic variants are associated with CLZ response and/or side effects.
Study population The investigators will include 2,500 patients diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS (together referred to as SCZ) >18 years of age who are currently on CLZ treatment or have used CLZ in the past. Publicly available Psychiatric Genomics Consortium (PGC) GWAS data will be used for comparisons with the broad schizophrenia phenotype group. For the purpose of the case-control comparison, the 2,500 subjects who use or have used CLZ will be age and sex-matched to 30,000 healthy control subjects for whom genotype data are available in-house.
Intervention No intervention will be applied.
Main study parameters/endpoints
- To assess whether the genetic architecture of this severe SCZ phenotype differs from the broad DSM-based SCZ phenotype.
- To predict clozapine response and side effects based on phenotypic and genetic data obtained in this study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Almost all patients on CLZ regularly have their blood drawn for routine white blood cell counts and/or CLZ blood level assessments. The investigators anticipate that the majority of the study population will consist of such patients as white blood cell monitoring is strictly enforced in clinical practice for this patient group. For these patients, no additional risks will be attached to the study, as the blood necessary for DNA extraction for the current study will be drawn during these routinely performed venipunctures. Time investment will also be low as the patients will only undergo a 10-minute interview. A minority of patients on CLZ does not have their blood routinely monitored and neither do patients who have used CLZ in the past. These subjects will be asked to allow a single blood draw. A venipuncture entails the risk of a hematoma (blood leaving the vessel). The investigators aim to minimize this risk by only allowing experienced personnel to draw blood and in the event of deeply located or thin veins request central lab personnel to perform the venipuncture. Although a hematoma resulting from a traumatic puncture imposes an esthetical burden on the subject, no serious health risks are involved.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current/former clozapine users | – | Other: Blood is obtained, mostly during routine venipunctureThis group has only one visit. |
| New clozapine users | – | Other: Blood is obtained, mostly during routine venipunctureThis group will be followed for 6 months prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will include 2,500 patients diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS (together referred to as SCZ) >18 years of age who are currently on CLZ treatment or have used CLZ in the past. Publicly available Psychiatric Genomics Consortium (PGC) GWAS data will be used for comparisons with the broad schizophrenia phenotype group. For the purpose of the case-control comparison, the 2,500 subjects who use or have used CLZ will be age and sex-matched to 13,000 healthy control subjects for whom genotype data are available in-house.
Key inclusion criteria (5 listed)
- he/she currently uses CLZ or he/she has used CLZ in the past/will use CLZ
- he/she has received a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS.
- his/her age must be ≥18 years old
- he/she must be able to speak and read the language of the Informed Consent (differs per country)
- he/she must be mentally competent and have decisional capacity with regard to a decision to participate in the current study
Key exclusion criteria (2 listed)
- admission to a psychiatric unit involuntarily (not all countries)
- a history of Parkinson's disease
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 |
|---|---|---|
| Blood is obtained, mostly during routine venipuncture | Other | Current/former clozapine users, New clozapine users |
Primary outcome
Predict clozapine response.
Time frame: 2016-2021
To predict clozapine response based on phenotypic information from our questionnaire (CGI + CRES) and genetic information from GWAS
Predict side effects from clozapine use
Time frame: 2016-2021
To predict clozapine response based on phenotypic information from our questionnaire (LUNSERS) and genetic information from GWAS
Assess differences in genetic architecture (GWAS)
Time frame: 2016-2021
To assess whether the genetic architecture of this severe SCZ phenotype differs from the broad DSM-based SCZ phenotype. this will be done by comparing the gentic material of clozapine users vs. non-clozapine users. Only the clozapine DNA has to be collected yet.
2 secondary outcomes
Detect genetic associations (GWAS) Detect genetic associations current severe SCZ phenotype
Time frame: 2016-2021
Increase or decrease cardiovascular disease?
Time frame: 2016-2031
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Website CLOZIN studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymous data can be shared with other investigators when the sponsor agreed on the workpackage of that investigator.
Related trials for Schizophrenia Spectrum and Other Psychotic Disorders
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 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
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
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.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Spectrum and Other Psychotic Disorders, run by Jurjen Luykx at 11 sites in 4 countries.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands, Germany, Austria, Finland. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marte van der Horst, Drs. (0887551460 ext. +31, mzvanderhorst@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict clozapine response. (time frame: 2016-2021). The study lists 3 primary outcomes in all. 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 5 Mar 2020.