SchizophreniaNCT02573168
Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment With Antipsychotics
A study testing GeneSight Psychotropic (GEN), Enhanced-GeneSight Psychotropic (E-GEN) and Treatment as Usual (TAU) in people with Schizophrenia and Schizoaffective Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Antipsychotics are approved to treat several conditions, including Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, and Major Depressive Disorder among others. The typical and atypical antipsychotics, derive their therapeutic benefit predominantly from the antagonism of dopamine D2 and 5-HT2A receptors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- GeneSight Psychotropic (GEN), Enhanced-GeneSight Psychotropic (E-GEN) and Treatment as Usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2020
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age or older;
- Suffer from schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified, bipolar disorder (I, II, NOS) or major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria;
- Have moderate to severe psychiatric symptoms;
- Intending to switch to, or start a new antipsychotic medication;:
- Be capable and willing to provide written informed consent to participate in this study;
- Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.
Who cannot join
- Patients posing a serious suicidal risk and/or violence as judged by the investigator;
- Patients with a current Axis I diagnosis of:
- Delirium
- Dementia
- Amnestic and other cognitive disorder;
- Patients who are on restricted diets (e.g., diabetes), who have an eating restriction disorder (e.g., bulimia, anorexia), or who are undergoing weight-reducing interventions (e.g. metformin, or structured diet program).
Show all 20Show fewer
- Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
- Patients who meet DSM-IV-TR criteria for any significant current substance dependence;
- Patients with:
- hepatic insufficiency (three times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)); liver transplant recipient; cirrhosis of the liver;
- malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
- significant unstable medical condition or life threatening disease with anticipated survival of less than 6 months;
- need for therapies that may obscure the results of treatment and/or of the study
- Participation in another clinical trial within 30 days of the screening visit;
- Anticipated inability to attend scheduled study visits;
- Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
- Patients with a history of prior pharmacogenomic testing;
- Any change in psychotropic medication (including change in dosage) between screening and baseline;
- Patients who are known to be pregnant or lactating;
- Patients with a history of gastric bypass surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-arm, Parallel Group, Multicentre, Double-blind, Randomized Controlled Trial Evaluating the Impact of GeneSight Psychotropic and Enhanced-GeneSight Psychotropic, on Change in Weight Following Antipsychotic Treatment in Patients Suffering From Disorders Indicated for Antipsychotic Utilization
Antipsychotics are approved to treat several conditions, including Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, and Major Depressive Disorder among others. The typical and atypical antipsychotics, derive their therapeutic benefit predominantly from the antagonism of dopamine D2 and 5-HT2A receptors. Many of these compounds are associated with common and significant adverse effects (e.g. weight gain, extrapyramidal symptoms, hyperprolactinemia, sexual dysfunction, and cardiac effects) which negatively impact on adherence. Today, antipsychotic induced weight gain (AIWG) is a leading cause for antipsychotic discontinuation. Importantly as well, approximately 20-30% of all patients with schizophrenia do not respond adequately to an initial antipsychotic trial, and strikingly, 83% of those who go on to a second antipsychotic trial do not meet criteria for response.
To-date, no RCT has been conducted to evaluate the outcomes in patients taking antipsychotics following the use of pharmacogenomic guidance of treatment selections. Therefore, the rationale for this trial is to utilize a double-blinded RCT design to evaluate and compare the clinical outcomes in participants treated with the benefit of GEN and E-GEN testing. Furthermore, this trial also intends to develop an evidence- based case for the value of GEN and E-GEN to Canadian health-care payers.
Read the detailed description
The primary objective for this study is to validate the clinical utility of the new Centre for Addiction in Mental Health (CAMH) antipsychotic induced weight gain (AIWG) markers and demonstrate the superior predictive capabilities of E-GEN as compared to GEN/TAU.
The second primary objective of this study is to compare the efficacy of GEN to treatment as usual (TAU) in improving response to psychotropic treatment in the subset of patients suffering from schizophrenia/schizoaffective disorder.
This study is designed as a three-arm multi-centre, double-blind (participants and raters), randomized controlled trial to compare the clinical and economic outcomes of GEN, E-GEN and TAU for patients suffering from psychiatric disorders indicated for antipsychotic utilization. Participants will be randomized in a 1:1:1 ratio to each of the three treatment arms. Recruitment will be 36-months and follow-up 12 months.
Subjects will complete short diagnostic interviews specific to their clinical diagnosis, basic metabolic measures (eg. blood pressure, weight), and provide buccal swab samples for genetic analysis (the unanalyzed buccal swabs and associated DNA will be biobanked). During the first visit, blood and urine samples will be required for laboratory panel screening and blood biobanking. Subjects will be monitored over a one year period and clinical measures and healthcare resource utilization will be obtained. Treating clinicians in the GEN and E-GEN arms will receive an easy to implement report providing pharmacogenomic guidance for prescribing psychotropic medications to their patients.
The study will recruit participants from 3 sites, stratified into 2 clusters. Chatham-Kent and Ontario Shores will form one of the stratified clusters. CAMH will constitute the second stratified cluster. The sample size required for this study was calculated for a large effect size (Cohen's d = 0.8) for weight change between treatment groups (GEN and E-GEN) and TAU. Sample size calculations are based on the weight gain differences observed between carriers and non-carriers of genetic risk markers in the CAMH discovery studies (18, 19, 20, 21, 22, 23). Assuming intraclass coefficient between clusters of 20%, statistical power of 80%, an alpha level of 0.05, and an expected drop-out rate of 28.3% by Week 12, a total of 90 participants (i.e., 30 per treatment arm) are required to detect the same effect in this study. Sample size calculations were determined using G*Power (version 3.1.9.2, Germany).
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- GeneSight Psychotropic (GEN), Enhanced-GeneSight Psychotropic (E-GEN), Treatment as Usual (TAU)
- Keywords
- Pharmacogenomic, Pharmacogenomic Testing, Pharmacogenomics, Genetic Testing, Genetics, GeneSight, Enhanced GeneSight, Psychotropic
- 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.
GeneSight Psychotropic (GEN)Genetic
Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
Enhanced-GeneSight Psychotropic (E-GEN)Genetic
The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study.
| Study group | Role | What they receive |
|---|---|---|
| GeneSight Psychotropic (GEN) | Experimental | The GeneSight Psychotropic (GEN) product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection. More specifically, patients are tested for clinically important genetic variants of multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to metabolize, tolerate or respond to medications. Receives: Genetic: GeneSight Psychotropic (GEN) |
| Enhanced-GeneSight Psychotropic (E-GEN) | Experimental | The current GEN test lacks predictive genes for antipsychotic-induced weight gain (AIWG), a major complication of antipsychotic drug use. Therefore, the Enhanced-GeneSight Psychotropic (E-GEN), which is an enhanced version of the GEN test, was developed by incorporating 6 new genes (represented by 7 SNPs) that are predictive for AIWG, to those used in the GEN algorithm. An increasing risk level associated with AIWG is estimated by an increasing number of risk genotypes that a given patient possesses among the 7 SNPs. Receives: Genetic: Enhanced-GeneSight Psychotropic (E-GEN) |
| Treatment as Usual (TAU) | Active comparator | The comparator chosen for this study provides a "real world" comparison of standard of care for patients who receive no pharmacogenomics guidance.
Patients randomized to the TAU arm will also have their DNA collected and a pharmacogenomic-based interpretive report will be generated using GEN testing. However, this report will not be shared with the treating clinicians until completion at 12 months of the study. Therefore, patients in this arm will receive clinical treatment as usual, without the use or knowledge of genotyping results by their treating clinicians. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients' weight and waist-to-hip ratio
Mean change in patients' weight and waist-to-hip ratio from baseline and week 12 of the study
Measured: From baseline to week 12
Change in schizophrenic symptoms as assessed by the Positive and Negative Syndrome
Mean change in the PANSS score from baseline to Week 12 of the study
Measured: From baseline to Week 12
Secondary outcomes (14)
Time between baseline and discontinuation of treatment for any cause
Measured: Baseline, Weeks 8 and 12, Months 6 and 12
Change in severity of illness as assessed by the Clinical Global Impression of Severity (CGI-S)
Measured: Baseline, Week 12, Months 6 and 12
Change in global improvement as assessed by Clinical Global Impression of Improvement (CGI-I)
Measured: Week 12, Months 6 and 12
Change in global therapeutic benefit and global severity of side effects as assessed by Clinical Global Impression Efficacy Index (CGI-EI)
Measured: Week 12, Months 6 and 12
Changes to initial prescribing based on availability of pharmacogenomic data
Measured: Screening and Baseline
Response rates to psychotropic medication
A responder is defined as a participant with 20% decrease in PANSS score from baseline.
Measured: Baseline, Weeks 8 and 12, Months 6 and 12
Time to response
Measured: Baseline, Weeks 8 and 12, Months 6 and 12
Change in psychotropic medication side effects as assessed by the Udvalg for Kliniske Undersogeler (UKU) Side Effect Rating Scale
Measured: Baseline, Weeks 8 and 12, Months 6 and 12
Change in severity of dyskinesias as assessed by the Abnormal Involuntary Movement Scale (AIMS)
Measured: Baseline and Month 12
Change in health related quality of life as assessed by the EuroQol (EQ-5D-5L)
Measured: Baseline, Week 12, Months 6 and 12
Change in health related quality of life as assessed by the Short Form (36) Health Survey (SF-36)
Measured: Baseline, Week 12, Months 6 and 12
Pharmacogenetics in Psychiatry Follow-Up Questionnaire (PIP-FQ)
The PIPFQ is a questionnaire developed by CAMH to evaluate each physician's attitude and experience to pharmacogenomic testing. Information is solicited from the physician on three different domains: the processing of the physician's last referral, the contact and outcome of the physician's patient, and the physician's perspective on the future of genetic studies in psychiatric drug treatment.
Measured: Baseline, when prescription changes are made (expected average of every 4 weeks), Months 6 and 12
Healthcare resource utilization (Composite measure of healthcare costs): physician visits, hospital utilization, emergency department visits, medication use, and laboratory tests
Measured: Baseline, Weeks 8 and 12, Months 6 and 12
Productivity losses (measured as economic costs)
Measured: Baseline, Weeks 8 and 12, Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2019
- Study completionSep 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Programs for Assessment of Technology in Health Research Institute, Centre for Addiction and Mental Health, Genome Canada, AssureRx Canada Ltd, Assurex Health Inc., Mars Excellence in Clinical Innovation and Technology Evaluation
- Responsible party
- Principal investigator, Jean-Eric Tarride, St. Joseph's Healthcare Hamilton
- Investigators
- Jean-Eric Tarride, PhD, Study chair, St.Joseph's Healthcare, Hamilton/Mcmaster UniversityJames L Kennedy, MD, Principal investigator, Centre for Addiction and Mental HealthBryan Dechairo, PhD, Principal investigator, Assurex Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573168
- Sponsor's protocol ID
- EXCITE-013304-ARX1010.PTL
- Status last verified
- Nov 2020
- First submitted
- 8 Oct 2015
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-arm, Parallel Group, Multicentre, Double-blind, Randomized Controlled Trial Evaluating the Impact of GeneSight Psychotropic and Enhanced-GeneSight Psychotropic, on Change in Weight Following Antipsychotic Treatment in Patients Suffering From Disorders Indicated for Antipsychotic Utilization
- ClinicalTrials.gov ID
- NCT02573168
- Acronym / sponsor ID
- EXCITE-013304-ARX1010.PTL
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Pharmacogenomic, Pharmacogenomic Testing, Pharmacogenomics, Genetic Testing, Genetics, GeneSight, Enhanced GeneSight, Psychotropic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Programs for Assessment of Technology in Health Research Institute, Centre for Addiction and Mental Health, Genome Canada, AssureRx Canada Ltd, Assurex Health Inc., Mars Excellence in Clinical Innovation and Technology Evaluation
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 9 Oct 2015 (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.
Antipsychotics are approved to treat several conditions, including Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, and Major Depressive Disorder among others. The typical and atypical antipsychotics, derive their therapeutic benefit predominantly from the antagonism of dopamine D2 and 5-HT2A receptors. Many of these compounds are associated with common and significant adverse effects (e.g. weight gain, extrapyramidal symptoms, hyperprolactinemia, sexual dysfunction, and cardiac effects) which negatively impact on adherence. Today, antipsychotic induced weight gain (AIWG) is a leading cause for antipsychotic discontinuation. Importantly as well, approximately 20-30% of all patients with schizophrenia do not respond adequately to an initial antipsychotic trial, and strikingly, 83% of those who go on to a second antipsychotic trial do not meet criteria for response.
To-date, no RCT has been conducted to evaluate the outcomes in patients taking antipsychotics following the use of pharmacogenomic guidance of treatment selections. Therefore, the rationale for this trial is to utilize a double-blinded RCT design to evaluate and compare the clinical outcomes in participants treated with the benefit of GEN and E-GEN testing. Furthermore, this trial also intends to develop an evidence- based case for the value of GEN and E-GEN to Canadian health-care payers.
Detailed description
The primary objective for this study is to validate the clinical utility of the new Centre for Addiction in Mental Health (CAMH) antipsychotic induced weight gain (AIWG) markers and demonstrate the superior predictive capabilities of E-GEN as compared to GEN/TAU.
The second primary objective of this study is to compare the efficacy of GEN to treatment as usual (TAU) in improving response to psychotropic treatment in the subset of patients suffering from schizophrenia/schizoaffective disorder.
This study is designed as a three-arm multi-centre, double-blind (participants and raters), randomized controlled trial to compare the clinical and economic outcomes of GEN, E-GEN and TAU for patients suffering from psychiatric disorders indicated for antipsychotic utilization. Participants will be randomized in a 1:1:1 ratio to each of the three treatment arms. Recruitment will be 36-months and follow-up 12 months.
Subjects will complete short diagnostic interviews specific to their clinical diagnosis, basic metabolic measures (eg. blood pressure, weight), and provide buccal swab samples for genetic analysis (the unanalyzed buccal swabs and associated DNA will be biobanked). During the first visit, blood and urine samples will be required for laboratory panel screening and blood biobanking. Subjects will be monitored over a one year period and clinical measures and healthcare resource utilization will be obtained. Treating clinicians in the GEN and E-GEN arms will receive an easy to implement report providing pharmacogenomic guidance for prescribing psychotropic medications to their patients.
The study will recruit participants from 3 sites, stratified into 2 clusters. Chatham-Kent and Ontario Shores will form one of the stratified clusters. CAMH will constitute the second stratified cluster. The sample size required for this study was calculated for a large effect size (Cohen's d = 0.8) for weight change between treatment groups (GEN and E-GEN) and TAU. Sample size calculations are based on the weight gain differences observed between carriers and non-carriers of genetic risk markers in the CAMH discovery studies (18, 19, 20, 21, 22, 23). Assuming intraclass coefficient between clusters of 20%, statistical power of 80%, an alpha level of 0.05, and an expected drop-out rate of 28.3% by Week 12, a total of 90 participants (i.e., 30 per treatment arm) are required to detect the same effect in this study. Sample size calculations were determined using G*Power (version 3.1.9.2, Germany).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GeneSight Psychotropic (GEN) | Experimental | Genetic: GeneSight Psychotropic (GEN)The GeneSight Psychotropic (GEN) product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection. More specifically, patients are tested for clinically important genetic variants of multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to metabolize, tolerate or respond to medications. |
| Enhanced-GeneSight Psychotropic (E-GEN) | Experimental | Genetic: Enhanced-GeneSight Psychotropic (E-GEN)The current GEN test lacks predictive genes for antipsychotic-induced weight gain (AIWG), a major complication of antipsychotic drug use. Therefore, the Enhanced-GeneSight Psychotropic (E-GEN), which is an enhanced version of the GEN test, was developed by incorporating 6 new genes (represented by 7 SNPs) that are predictive for AIWG, to those used in the GEN algorithm. An increasing risk level associated with AIWG is estimated by an increasing number of risk genotypes that a given patient possesses among the 7 SNPs. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)The comparator chosen for this study provides a "real world" comparison of standard of care for patients who receive no pharmacogenomics guidance. Patients randomized to the TAU arm will also have their DNA collected and a pharmacogenomic-based interpretive report will be generated using GEN testing. However, this report will not be shared with the treating clinicians until completion at 12 months of the study. Therefore, patients in this arm will receive clinical treatment as usual, without the use or knowledge of genotyping results by their treating clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older;
- Suffer from schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified, bipolar disorder (I, II, NOS) or major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria;
- Have moderate to severe psychiatric symptoms;
- Intending to switch to, or start a new antipsychotic medication;:
- Be capable and willing to provide written informed consent to participate in this study;
Key exclusion criteria (20 listed)
- Patients posing a serious suicidal risk and/or violence as judged by the investigator;
- Patients with a current Axis I diagnosis of:
- Patients who are on restricted diets (e.g., diabetes), who have an eating restriction disorder (e.g., bulimia, anorexia), or who are undergoing weight-reducing interventions (e.g. metformin, or structured diet program).
- Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
- Patients who meet DSM-IV-TR criteria for any significant current substance dependence;
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 |
|---|---|---|
| GeneSight Psychotropic (GEN)Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support their treatment decisions. | Genetic | GeneSight Psychotropic (GEN) |
| Enhanced-GeneSight Psychotropic (E-GEN)The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions. | Genetic | Enhanced-GeneSight Psychotropic (E-GEN) |
| Treatment as Usual (TAU)Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study. | Other | Treatment as Usual (TAU) |
Primary outcome
Change in patients' weight and waist-to-hip ratio
Time frame: From baseline to week 12
Mean change in patients' weight and waist-to-hip ratio from baseline and week 12 of the study
Change in schizophrenic symptoms as assessed by the Positive and Negative Syndrome
Time frame: From baseline to Week 12
Mean change in the PANSS score from baseline to Week 12 of the study
14 secondary outcomes
Time between baseline and discontinuation of treatment for any cause
Time frame: Baseline, Weeks 8 and 12, Months 6 and 12
Change in severity of illness as assessed by the Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline, Week 12, Months 6 and 12
Change in global improvement as assessed by Clinical Global Impression of Improvement (CGI-I)
Time frame: Week 12, Months 6 and 12
Change in global therapeutic benefit and global severity of side effects as assessed by Clinical Global Impression Efficacy Index (CGI-EI)
Time frame: Week 12, Months 6 and 12
Changes to initial prescribing based on availability of pharmacogenomic data
Time frame: Screening and Baseline
Response rates to psychotropic medication
Time frame: Baseline, Weeks 8 and 12, Months 6 and 12
Time to response
Time frame: Baseline, Weeks 8 and 12, Months 6 and 12
Change in psychotropic medication side effects as assessed by the Udvalg for Kliniske Undersogeler (UKU) Side Effect Rating Scale
Time frame: Baseline, Weeks 8 and 12, Months 6 and 12
Change in severity of dyskinesias as assessed by the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline and Month 12
Change in health related quality of life as assessed by the EuroQol (EQ-5D-5L)
Time frame: Baseline, Week 12, Months 6 and 12
Change in health related quality of life as assessed by the Short Form (36) Health Survey (SF-36)
Time frame: Baseline, Week 12, Months 6 and 12
Pharmacogenetics in Psychiatry Follow-Up Questionnaire (PIP-FQ)
Time frame: Baseline, when prescription changes are made (expected average of every 4 weeks), Months 6 and 12
Healthcare resource utilization (Composite measure of healthcare costs): physician visits, hospital utilization, emergency department visits, medication use, and laboratory tests
Time frame: Baseline, Weeks 8 and 12, Months 6 and 12
Productivity losses (measured as economic costs)
Time frame: Baseline, Weeks 8 and 12, Months 6 and 12
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 19 Nov 2020.
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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.
Jean-Eric Tarride, PhD study chair
St.Joseph's Healthcare, Hamilton/Mcmaster University
James L Kennedy, MD principal investigator
Centre for Addiction and Mental Health
Bryan Dechairo, PhD principal investigator
Assurex Health Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GeneSight Psychotropic (GEN), Enhanced-GeneSight Psychotropic (E-GEN) and Treatment as Usual (TAU) in people with Schizophrenia and Schizoaffective Disorder, run by St. Joseph's Healthcare Hamilton 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 6 inclusion and 20 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 19 Nov 2020. 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 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?
Change in patients' weight and waist-to-hip ratio (time frame: From baseline to week 12). The study lists 2 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 19 Nov 2020.