DepressionNCT01261364
Pharmacogenetic-Directed Treatment for Major Depression
A study testing GeneSightRx and Treatment as usual in people with Depression, run by Assurex Health Inc..
Trial summary
Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- GeneSightRx and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Disorder (296.2, 296.3) or Depressive Disorder NOS (311.0) by a board certified psychiatrist.
- The patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study.
- The patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons.
- Patient's baseline 17-Item Hamilton Depression (HAMD17) Rating score is >14.
- Provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine.
- Undergo a medical history that includes a review of major organ systems by either their treating clinician, a subinvestigator physician, or a study-contracted physician assistant in internal medicine.
- The patient has signed the study informed consent form.
Who cannot join
- Serious medical illness (as ascertained via inclusion criteria 6 and 7, above).
- Diagnosis of a Bipolar Disorder.
- Diagnosis of Schizophrenia or Schizoaffective disorder.
- Evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. Patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. Patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication.
- History of prior pharmacogenomic testing.
About this study
Official title: The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study
Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.
Read the detailed description
This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications
- Conditions
- Depression
- Being tested
- GeneSightRx, Treatment as usual
- Keywords
- GeneSight, Assurex, AssureRx
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneSightRxBehavioural
Multi-genetic pharmacogenomic panel
Treatment as usualBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Not described Receives: Behavioral: Treatment as usual |
| Pharmacogenetic guided treatment | Experimental | Not described Receives: Behavioral: GeneSightRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Score reduction
Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.
Measured: 8 weeks
Side effect reduction
Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.
Measured: 8 weeks
Secondary outcomes (8)
Depression response or remission
Percentage of subjects who respond (≥50% decrease in HAMD17 and QIDS-CR* rating) or remit (HAMD17< 7 and QIDS-CR rating < 5) with PGx-guided treatment.
Measured: 8 weeks
Time to response/remission of depressive symptoms.
Time to response/remission of depressive symptoms.
Measured: 8 weeks
Medication change
Number of subjects who changed their baseline antidepressant medication regimens.
Measured: 8 weeks
Health care clinical cost
Health care clinical cost (defined by mental health resource utilization).
Measured: 8 weeks
Report availability
Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient.
Measured: 8 weeks
Medication Choice
Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.
Measured: 8 weeks
Physician satisfaction
Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Measured: 8 weeks
Patient Satisfaction
Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionSep 2011
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assurex Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pine Rest Christian Mental Health Services
- Responsible party
- Sponsor
- Investigators
- Kevin Furmaga, PharmD, Principal investigator, Pine Rest Mental Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261364
- Sponsor's protocol ID
- 10002
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study
- ClinicalTrials.gov ID
- NCT01261364
- Acronym / sponsor ID
- 10002
- Conditions
- Depression
- Keywords
- GeneSight, Assurex, AssureRx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assurex Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pine Rest Christian Mental Health Services
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Dec 2010 (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.
Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.
Detailed description
This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Treatment as usual |
| Pharmacogenetic guided treatment | Experimental | Behavioral: GeneSightRx |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Major Depressive Disorder (296.2, 296.3) or Depressive Disorder NOS (311.0) by a board certified psychiatrist.
- The patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study.
- The patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons.
- Patient's baseline 17-Item Hamilton Depression (HAMD17) Rating score is >14.
- Provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine.
Key exclusion criteria (5 listed)
- Serious medical illness (as ascertained via inclusion criteria 6 and 7, above).
- Diagnosis of a Bipolar Disorder.
- Diagnosis of Schizophrenia or Schizoaffective disorder.
- Evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. Patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. Patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication.
- History of prior pharmacogenomic testing.
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 |
|---|---|---|
| GeneSightRxMulti-genetic pharmacogenomic panel | Behavioural | Pharmacogenetic guided treatment |
| Treatment as usualTreatment as usual | Behavioural | Treatment as Usual |
Primary outcome
Depression Score reduction
Time frame: 8 weeks
Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.
Side effect reduction
Time frame: 8 weeks
Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.
8 secondary outcomes
Depression response or remission
Time frame: 8 weeks
Time to response/remission of depressive symptoms.
Time frame: 8 weeks
Medication change
Time frame: 8 weeks
Health care clinical cost
Time frame: 8 weeks
Report availability
Time frame: 8 weeks
Medication Choice
Time frame: 8 weeks
Physician satisfaction
Time frame: 8 weeks
Patient Satisfaction
Time frame: 8 weeks
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 3 Dec 2015.
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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.
Kevin Furmaga, PharmD principal investigator
Pine Rest Mental Health Service
Questions about this trial
What is this clinical trial studying?
A study testing GeneSightRx and Treatment as usual in people with Depression, run by Assurex Health Inc..
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 7 inclusion and 5 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 3 Dec 2015. 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.
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?
Depression Score reduction (time frame: 8 weeks). 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 3 Dec 2015.