SchizophreniaNCT00701753
A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
An observational study of Schizophrenia and Schizoaffective Disorder, run by TheraGenetics Limited at 1 site in Canada.
Trial summary
An individual's genetic make-up is known to determine their response to antipsychotic medication. Genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Mar 2009
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of Vancouver Coastal Health
Who may be able to join
- Written informed consent must be obtained
- DSM-IV diagnosis must be one of:
- schizophrenia
- schizophreniform
- schizoaffective
- delusional disorder
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- brief reactive psychosis
- psychosis not otherwise specified
- Ethnic origin of both parents must be known
- A minimum of 6 weeks continuous treatment completed with the given antipsychotic, prescribed at least at minimum recommended doses
- Prospectively collected outcome data available (pre-treatment and after at least 6 weeks on treatment)
Who cannot join
- Significant psychiatric or medical co-morbidity including history of:
- head injury with loss of consciousness
- seizures
- neurological disorder
- mental retardation (DSM-IV)
- drug or alcohol dependence (DSM-IV)
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- serious physical illness e.g. malignancy, hepatic/renal insufficiency
- Concomitant psychotropic medication that may influence ratings
- Concomitant antipsychotics, antidepressants or mood stabilisers prescribed for >2 weeks during the antipsychotic treatment period rated
Trial locations and contacts
1 site in 1 country.
About this study
An individual's genetic make-up is known to determine their response to antipsychotic medication. Genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome.
The study is a naturalistic study of routinely prescribed antipsychotics using outcome measures undertaken as part of the routine clinical care of the cohort. These clinical data are linked with genetic information obtained from DNA and RNA from blood samples undertaken as part of the study.
Read more
No alteration is made to the subjects treatment regime or medication.
The study is a two stage investigation:
- The first stage involves the collection of a databank of clinical information and blood samples for DNA and RNA extraction from patients treated with antipsychotic medication.
- The second stage is a molecular genetic investigation of treatment-related genetic factors that may contribute to response prediction and predisposition to side effects.
From these genetic studies pharmacogenetic prediction tests will be validated and/or developed.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Pharmacogenetic, DNA, RNA, Antipsychotic, Olanzapine, Risperidone, Quetiapine, Personalized medicine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Subjects treated with olanzapine as part of their routine clinical care | |
| Risperidone | Subjects treated with risperidone as part of their routine clinical care | |
| Quetiapine | Subjects treated with quetiapine as part of their routine clinical care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Insufficient subject recruitment.
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
- Observational
- Observational model
- Case only
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TheraGenetics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Soma Ganesan, MD, Principal investigator, Vancouver Coastal HealthJanet Munro, MB BS, Study director, TheraGenetics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701753
- Sponsor's protocol ID
- TheraGenetics-002
- Status last verified
- Mar 2009
- First submitted
- 17 Jun 2008
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
- ClinicalTrials.gov ID
- NCT00701753
- Acronym / sponsor ID
- TheraGenetics-002
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Pharmacogenetic, DNA, RNA, Antipsychotic, Olanzapine, Risperidone, Quetiapine, Personalized medicine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient subject recruitment.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TheraGenetics LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Jun 2008 (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.
An individual's genetic make-up is known to determine their response to antipsychotic medication. Genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome.
The study is a naturalistic study of routinely prescribed antipsychotics using outcome measures undertaken as part of the routine clinical care of the cohort. These clinical data are linked with genetic information obtained from DNA and RNA from blood samples undertaken as part of the study.
No alteration is made to the subjects treatment regime or medication.
The study is a two stage investigation:
- The first stage involves the collection of a databank of clinical information and blood samples for DNA and RNA extraction from patients treated with antipsychotic medication.
- The second stage is a molecular genetic investigation of treatment-related genetic factors that may contribute to response prediction and predisposition to side effects.
From these genetic studies pharmacogenetic prediction tests will be validated and/or developed.
Study design
- Observational model
- Case only
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | – | –Subjects treated with olanzapine as part of their routine clinical care |
| Risperidone | – | –Subjects treated with risperidone as part of their routine clinical care |
| Quetiapine | – | –Subjects treated with quetiapine as part of their routine clinical care |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Vancouver Coastal Health
Key inclusion criteria (11 listed)
- Written informed consent must be obtained
- DSM-IV diagnosis must be one of:
- Ethnic origin of both parents must be known
- A minimum of 6 weeks continuous treatment completed with the given antipsychotic, prescribed at least at minimum recommended doses
- Prospectively collected outcome data available (pre-treatment and after at least 6 weeks on treatment)
Key exclusion criteria (9 listed)
- Significant psychiatric or medical co-morbidity including history of:
- Concomitant psychotropic medication that may influence ratings
- Concomitant antipsychotics, antidepressants or mood stabilisers prescribed for >2 weeks during the antipsychotic treatment period rated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Insufficient subject recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
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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.
Soma Ganesan, MD principal investigator
Vancouver Coastal Health
Janet Munro, MB BS study director
TheraGenetics Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by TheraGenetics Limited 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Mar 2009. 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient subject recruitment.). Results are not available in the source record.
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.
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 12 Mar 2009.