Major Depressive DisorderNCT01438242
An Open Label Study of the Genecept™ Assay in Treatment Resistant Depression
A study testing Genecept Assay in people with Major Depressive Disorder, run by Genomind, LLC at 1 site in United States.
Trial summary
The purpose of this study is to examine the potential impact of the assay in terms of depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Genecept Assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Ability to complete electronic informed consent
- Includes:
- access to appropriate technology (i.e. internet-connected device, internet connection),
- cognitively competent
- Eligible participants will have one or more of the following diagnoses for 12 months or longer: 296.2x, 296.3x
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- Must have had self-insured Aetna Behavioral Health, Medical, and Pharmacy benefits for that 12-month period.
- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
- Must have had an initial prescription plus two refills of two antidepressants from different GPI4 levels.
- Must have access to the secure web-portal to complete self-assessments
- Treating clinician for potential Patient subjects identified for the study
- Valid NPI number
- Signed electronic informed consent
Who cannot join
- Clinician selected in conjunction with the patient chooses not to participate
- Psychotic features in the current episode, based upon clinical assessment
- Inpatient behavioral health hospitalization within six months prior to the study
- Four or more failed pharmacologic interventions in the current major depressive episode [response rates for these Subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects]
- Current substance use disorder assessed as being of a severity that requires inpatient or outpatient detoxification
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception
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- Women who are breastfeeding
- Serious suicide or homicide risk, as assessed by evaluating clinician
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests
- Patients who have taken an investigational psychotropic drug within the last three months
- Clinician Study Participants:
- Inability to complete online surveys
- Patient selected in conjunction with the clinician chooses not to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study of the Genecept™ Assay to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression
The purpose of this study is to examine the potential impact of the assay in terms of depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3 months.
Read the detailed description
Genomind is sponsoring an open label study of Assay Guided Treatment (AGT) using the Genecept Assay in adult outpatients with Treatment Resistant Major Depressive Disorder. The Genecept Assay is a Clinical Laboratory Improvement Amendments (CLIA) laboratory validated test being researched to determine if having information about genetic variations impacts patient outcomes.
The proposed investigation will examine the potential impact of the Assay in terms of depression severity as measured by change in CGI scale at 3 months. Secondary measures will assess change in Quick Inventory of Depressive Symptoms (QIDS-SR), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months. Additional measures include change in clinician treatment and diagnosis decisions and impact on mediation side effects using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU). Participant data will be compared to a matched control cohort to assess the impact of the use of the Genecept Assay on medication adherence and total claims.
Patients with a diagnosis of non-psychotic Major Depressive Disorder will be identified. These patients and their treating clinicians will be recruited. The present study proposes to enroll 1. Subjects (patients who are identified as eligible) and 2. Clinician study participants (clinicians who are identified as responsible for the care of eligible patients). This study will involve the collection of responses from both Subjects and clinician study participants with the intention of correlating this information to Subject genetic data.
Potential subjects and study participants will consent electronically on a secure study portal. Patients and Clinicians must both consent to participate in order to proceed in the study. After both subjects and clinician study participants have consent to participate, they will each be asked to complete an electronic baseline survey. Once the baseline survey is completed, the clinician will receive the Genecept Assay by mail and will then supervise collection of a saliva DNA sample during a routine office visit.
At baseline, month 1 and month 3, patient Subjects will be prompted to complete surveys which include questions about their psychiatric symptoms, quality of life and medication side effects. The 3 month patient assessment will also include a satisfaction questionnaire.
At baseline, clinician study participants will be prompted to complete a brief survey containing questions about the patient's psychiatric history and severity of illness, current treatment regimen and the treatment intentions of the clinician prior to receiving genetic results. After receiving the results of the Assay, clinician study participants will again be prompted to complete an online study survey containing questions related to the impact of the Genecept Assay on treatment and diagnosis decisions. The subject will continue with treatment as determined by the clinician study participant. At 3 months from baseline, clinician study participants will again be asked to complete an online survey with additional questions related to subsequent changes to the patient's treatment regimen and illness severity since receiving/implementing the results of the Assay.
- Conditions
- Major Depressive Disorder
- Being tested
- Genecept Assay
- Keywords
- Major, Depressive, Disorder, Depression, Treatment Resistant
- Medical subject headings
- Depressive Disorder, Major, Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genecept AssayDevice
Also called Genetic Test
Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
| Study group | Role | What they receive |
|---|---|---|
| Assay Guided Treatment - Genecept Asay | Experimental | Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account. Genetic analysis is performed using the Genecept Assay, a genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders Receives: Device: Genecept Assay |
| Clinician's utilizing Assay Guided Treatment in Psychiatry | Experimental | Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing. Receives: Device: Genecept Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Clinical Global Impressions (CGI) scale at 3 months.
Measured: 3 Months
Secondary outcomes (5)
Efficacy
To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Quick Inventory of Depressive Symptoms (QIDS-SR1), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months.
Measured: 3 months
Medication Adherence
To compare medication adherence between Patient subjects and matched control cohort
Measured: 3 months
Resource Utilization
To determine the comparative effectiveness of AGT versus Treatment as Usual (TAU) in a matched control cohort in outpatient management of nonpsychotic Major Depressive Disorder patients with treatment resistant depression, as measured by total claims.
Measured: 3 months
Impact of Specific Genetic Variants
- To explore genetic variants within the patient population and identify subgroups for whom pharmacogenetic testing is particularly informative
- To determine which specific results of pharmacogenetic testing have the most impact on clinician behavior
Measured: 3 months
Side Effects
To explore genetic variants in relationship to classes of medications and treatment response as measured by CGI and QIDs, and change in reported adverse events using the UKU (The Udvalg for Kliniske Undersøgelser Side Effect Rating Scale.)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genomind, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert Harris, MD, PhD, Principal investigator, Rho, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438242
- Sponsor's protocol ID
- AT1
- Status last verified
- Mar 2015
- First submitted
- 20 Sep 2011
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Genecept™ Assay to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT01438242
- Acronym / sponsor ID
- AT1
- Conditions
- Major Depressive Disorder
- Keywords
- Major, Depressive, Disorder, Depression, Treatment Resistant
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genomind, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 22 Sep 2011 (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.
The purpose of this study is to examine the potential impact of the assay in terms of depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3 months.
Detailed description
Genomind is sponsoring an open label study of Assay Guided Treatment (AGT) using the Genecept Assay in adult outpatients with Treatment Resistant Major Depressive Disorder. The Genecept Assay is a Clinical Laboratory Improvement Amendments (CLIA) laboratory validated test being researched to determine if having information about genetic variations impacts patient outcomes.
The proposed investigation will examine the potential impact of the Assay in terms of depression severity as measured by change in CGI scale at 3 months. Secondary measures will assess change in Quick Inventory of Depressive Symptoms (QIDS-SR), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months. Additional measures include change in clinician treatment and diagnosis decisions and impact on mediation side effects using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU). Participant data will be compared to a matched control cohort to assess the impact of the use of the Genecept Assay on medication adherence and total claims.
Patients with a diagnosis of non-psychotic Major Depressive Disorder will be identified. These patients and their treating clinicians will be recruited. The present study proposes to enroll 1. Subjects (patients who are identified as eligible) and 2. Clinician study participants (clinicians who are identified as responsible for the care of eligible patients). This study will involve the collection of responses from both Subjects and clinician study participants with the intention of correlating this information to Subject genetic data.
Potential subjects and study participants will consent electronically on a secure study portal. Patients and Clinicians must both consent to participate in order to proceed in the study. After both subjects and clinician study participants have consent to participate, they will each be asked to complete an electronic baseline survey. Once the baseline survey is completed, the clinician will receive the Genecept Assay by mail and will then supervise collection of a saliva DNA sample during a routine office visit.
At baseline, month 1 and month 3, patient Subjects will be prompted to complete surveys which include questions about their psychiatric symptoms, quality of life and medication side effects. The 3 month patient assessment will also include a satisfaction questionnaire.
At baseline, clinician study participants will be prompted to complete a brief survey containing questions about the patient's psychiatric history and severity of illness, current treatment regimen and the treatment intentions of the clinician prior to receiving genetic results. After receiving the results of the Assay, clinician study participants will again be prompted to complete an online study survey containing questions related to the impact of the Genecept Assay on treatment and diagnosis decisions. The subject will continue with treatment as determined by the clinician study participant. At 3 months from baseline, clinician study participants will again be asked to complete an online survey with additional questions related to subsequent changes to the patient's treatment regimen and illness severity since receiving/implementing the results of the Assay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assay Guided Treatment - Genecept Asay | Experimental | Device: Genecept AssaySubjects donate DNA sample for genetic testing and treatment decisions take genetic results into account. Genetic analysis is performed using the Genecept Assay, a genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders |
| Clinician's utilizing Assay Guided Treatment in Psychiatry | Experimental | Device: Genecept AssayPrescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-65 years
- Ability to complete electronic informed consent
- access to appropriate technology (i.e. internet-connected device, internet connection),
- cognitively competent
- Treating clinician for potential Patient subjects identified for the study
Key exclusion criteria (13 listed)
- Clinician selected in conjunction with the patient chooses not to participate
- Psychotic features in the current episode, based upon clinical assessment
- Inpatient behavioral health hospitalization within six months prior to the study
- Four or more failed pharmacologic interventions in the current major depressive episode [response rates for these Subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects]
- Current substance use disorder assessed as being of a severity that requires inpatient or outpatient detoxification
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 |
|---|---|---|
| Genecept AssayAlso: Genetic TestGenetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders | Device | Assay Guided Treatment - Genecept Asay, Clinician's utilizing Assay Guided Treatment in Psychiatry |
Primary outcome
Efficacy
Time frame: 3 Months
To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Clinical Global Impressions (CGI) scale at 3 months.
5 secondary outcomes
Efficacy
Time frame: 3 months
Medication Adherence
Time frame: 3 months
Resource Utilization
Time frame: 3 months
Impact of Specific Genetic Variants
Time frame: 3 months
Side Effects
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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.
Herbert Harris, MD, PhD principal investigator
Rho, 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 Genecept Assay in people with Major Depressive Disorder, run by Genomind, LLC at 1 site in United States.
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 13 inclusion and 13 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: withdrawn, as of the sponsor's last update on 23 Mar 2015. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Efficacy (time frame: 3 Months). 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 23 Mar 2015.