AzTrials
AzTrials

Treatment Resistant DepressionCOM-1NCT01507155

An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay

A study testing Genecept Assay in people with Treatment Resistant Depression and Generalized Anxiety Disorder, run by Genomind, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which clinicians can administer to patients using a simple saliva sample technique. The present study proposes to enroll 1. Subjects (patients who have consented to using the Genecept Assay) and 2. Read more about this study

Who is it for?
Ages 18 years and older
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
685 participants
Where
1 siteUnited States
Study dates
Apr 2013to May 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Clinician Study Participants:
  • Valid National Provider Identifier (NPI) number and prescribing privileges
  • Signed electronic informed consent
  • Signed requisitions form for order of Genecept Assay
  • Requisition form includes indication of diagnosis of depression or anxiety for patient
  • Subject Study Participants:
Show all 11Show fewer
  • Ability to complete electronic informed consent; includes:
  • access to appropriate technology (i.e. internet-connected device, internet connection),
  • cognitively competent
  • > or = 18 years old at time of DNA sample collection
  • Indication of diagnosis of depression or anxiety on requisition form

Who cannot join

  • Clinician Study Participants:
  • Inability to complete online questionnaires
  • Subject Study Participants:
  • Inability to complete online questionnaires;includes:
  • lack of access to appropriate technology (i.e. internet-connected device, internet connection),
  • cognitive impairment
  • < 18 years old at time of DNA sample collection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Genomind, LLC

    Chalfont, Pennsylvania, 18914

Other trials in United States

About this study

Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which clinicians can administer to patients using a simple saliva sample technique. The present study proposes to enroll 1. Subjects (patients who have consented to using the Genecept Assay) and 2. Clinician study participants (clinicians who have ordered the Assay on behalf of their 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.

Read the detailed description

This will be a 3-month prospective study of clinicians who have ordered the Genecept assay and the psychiatric patients for whom the test was ordered. Clinicians who order the Assay for a patient who has been indicated as having a diagnosis of depression will receive an invitation to participate in this study as well as an informational patient study brochure with the test kit. The patient's treating clinician will be prompted to discuss the study with the patient. Clinicians and patients can view a website containing additional information about the study as well as the informed consent document.

Potential subjects and clinician study participants will be consented online using a secure electronic method. Study staff will be available by phone and by email to answer any questions related to the study and the informed consent documents and process. Clinicians and patients can choose to participate independently of each other so that if one party declines to enroll, the other may still participate. Whether or not they choose to participate, patients must consent to allow their clinicians to provide responses about their treatment.

All subjects and participants will receive a username and password with which to access the secure study portal for completion of study surveys. Subjects and participants will receive sms and email reminders when surveys are due.

At baseline, clinician study participants will supervise DNA sample collection and 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.

The subject will also be prompted to complete surveys at baseline, 1 month from the receipt of the genetic results and 3 months from the receipt of the genetic results. These surveys include questions about the patient's psychiatric symptoms, quality of life and medication side effects. The 3 month patient assessment will also include a satisfaction questionnaire.

Being tested
Genecept Assay
Keywords
Major, Depressive, Disorder, Depression, MDD, Treatment Resistant, Anxiety, GAD
Medical subject headings
Depressive Disorder, Treatment-Resistant, Generalized Anxiety Disorder, Disease, Depression, Anxiety Disorders

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 groups in NCT01507155
Study groupRoleWhat they receive
Patient-Reported MeasuresExperimentalPatients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who received genetic testing using the Genecept Assay and completed patient scales.
Receives: Device: Genecept Assay
Clinician-Reported OutcomesExperimentalPrescribing 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.

  1. Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months

    To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).

    Measured: 3 months

Secondary outcomes (1)

  1. Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months

    To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales:

    1. Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression
    2. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life
    3. Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating
    4. the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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
685 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01507155
Sponsor's protocol ID
COM-1
Acronym
COM-1
Status last verified
May 2016
First submitted
6 Jan 2012
Last updated
8 Jun 2016
Data monitoring committee
No

Publications

  • Brennan FX, Gardner KR, Lombard J, Perlis RH, Fava M, Harris HW, Scott R. A Naturalistic Study of the Effectiveness of Pharmacogenetic Testing to Guide Treatment in Psychiatric Patients With Mood and Anxiety Disorders. Prim Care Companion CNS Disord. 2015 Apr 16;17(2):10.4088/PCC.14m01717. doi: 10.4088/PCC.14m01717. eCollection 2015.

    PubMed 26445691

Questions about this trial

What is this clinical trial studying?

A study testing Genecept Assay in people with Treatment Resistant Depression and Generalized Anxiety 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 11 inclusion and 7 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 8 Jun 2016. 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?

Yes. Results are posted in the registry (first posted 2 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01507155, which also lists 1 linked publication.

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 8 Jun 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in