DepressionPhase 3NCT03232502
Pharmacogenetics in Primary Care Psychotropics
A Phase 3 study testing Pharmacogenetic testing in people with Depression and Obsessive-Compulsive Disorder, run by University of Arizona.
Trial summary
Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder
- What is being tested?
- Pharmacogenetic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2017to 31 Dec 2018
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18
- Prescribed a drug of interest for the first time
Who cannot join
- Previous pharmacogenetic testing available
About this study
Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?
- Being tested
- Pharmacogenetic testing
- Medical subject headings
- Depression, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testingDiagnostic test
Basic pharmacogenetic panel
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Diagnostic Test: Pharmacogenetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient oriented outcome1- Clinical Improvement
Clinically significant improvement as noted by physician (Subjective and PHQ-9)
Measured: 6 months
Patient oriented outcome2- Adverse effects
Number of patients with specific, common side effects (from medical chart)
Measured: 6 months
Patient oriented outcome3- Time to Improvement
Days to clinical improvement (from medical chart)
Measured: Up to 6 months
Patient oriented outcome5- Visits
Total number of visits to clinic with medication titration required (from medical chart)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start15 Aug 2017 (estimated)
- Primary completion15 Jan 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232502
- Sponsor's protocol ID
- Pending1
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics in Primary Care Psychotropics
- ClinicalTrials.gov ID
- NCT03232502
- Acronym / sponsor ID
- Pending1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Aug 2017 (estimated)
- Primary completion
- 15 Jan 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Jul 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.
Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Diagnostic Test: Pharmacogenetic testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18
- Prescribed a drug of interest for the first time
Key exclusion criteria (1 listed)
- Previous pharmacogenetic testing available
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 |
|---|---|---|
| Pharmacogenetic testingBasic pharmacogenetic panel | Diagnostic test | Intervention |
Primary outcome
Patient oriented outcome1- Clinical Improvement
Time frame: 6 months
Clinically significant improvement as noted by physician (Subjective and PHQ-9)
Patient oriented outcome2- Adverse effects
Time frame: 6 months
Number of patients with specific, common side effects (from medical chart)
Patient oriented outcome3- Time to Improvement
Time frame: Up to 6 months
Days to clinical improvement (from medical chart)
Patient oriented outcome5- Visits
Time frame: 6 months
Total number of visits to clinic with medication titration required (from medical chart)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pharmacogenetic testing in people with Depression and Obsessive-Compulsive Disorder, run by University of Arizona.
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 2 inclusion and 1 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 28 Jul 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Patient oriented outcome1- Clinical Improvement (time frame: 6 months). The study lists 4 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 28 Jul 2017.