Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Genomind, LLC
Sponsor:
Information provided by (Responsible Party):
Genomind, LLC
ClinicalTrials.gov Identifier:
NCT01426516
First received: August 29, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials. Such treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs of MDD, in terms of health care costs, functional impairment, and diminished quality of life.

The promise of personalized medicine for individuals at high risk for TRD is apparent. If these individuals could be recognized early in their disease course, they could be triaged to more intensive or targeted interventions to improve their likelihood of remission. With the proliferation of treatment options in MDD, at present individuals can spend months or years in and out of treatment before receiving these next-step treatments.

At present, no clinical or biomarker-based tool has been shown to assist in matching patients with treatments most likely to be effective for them. The Genecept Assay offers the possibility of "Personalized Medicine" in psychiatry. Clinicians may find this additional genetic information can lead to optimized treatment plans for individual patients. Before such an assay can be widely applied clinically, it is necessary to demonstrate that this tool usefully impacts treatment outcomes.

This study will examine the potential impact of the assay in terms of depression severity at 3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate of its potential to change clinician behavior and improve patient quality of life. Further measures will also allow for refinement of the assay to maximize patient and clinician satisfaction, and estimate the potential savings associated with deployment of this assay in real-world clinical settings.


Condition Intervention
Major Depressive Disorder
Device: Genecept Assay

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Six-month Study of the Genecept Assay vs. Treatment as Usual to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression

Resource links provided by NLM:


Further study details as provided by Genomind, LLC:

Primary Outcome Measures:
  • Efficacy measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months

    Add:

    • highest score on any 1 of the 4 sleep items (items 1 to 4)
    • highest score on any 1 of the 4 weight items (items 6 to 9)
    • highest score on either of the 2 psychomotor items (15 and 16)
    • scores for each of the 6 MDD symptom domains

    Total scores range from 0-27



Secondary Outcome Measures:
  • Clinician Behavior as measured by change in recorded treatment choice before and after the assay results are made available. [ Time Frame: one week ] [ Designated as safety issue: No ]
    Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.

  • Quality of Life as measured by self reported assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]
    To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.

  • Cost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.

  • Acceptability of the use of AGT for Subjects and Clinicians as measured by satisfaction survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual (TAU)
Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
Experimental: Genecept Assay
Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Device: Genecept Assay
Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
Other Name: Genetic Test

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-65
  • written informed consent
  • diagnosis of non-psychotic major depression as determined by study
  • clinician/current medical prescriber, and mood disorder diagnosis confirmed by PHQ-9
  • QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
  • failure of at least 1 prior adequate trial of a standard antidepressant (by ATRQ criteria - i.e., 6 weeks at adequate dose)

Exclusion Criteria:

  • psychotic features in the current episode, based upon clinical assessment
  • 4 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 other than nicotine which based upon clinical assessment requires inpatient or outpatient detoxification
  • pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
  • women who are breastfeeding
  • serious suicide or homicide risk, as assessed by evaluating clinician
  • other 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 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426516

Contacts
Contact: Rachel Dicker, PharmD 215-396-5594 Rachel.Dicker@genomind.com

Locations
United States, Tennessee
Centerstone Recruiting
Nashville, Tennessee, United States, 37228
Contact: Vivian Park, MS         
Principal Investigator: Karen Rhea, MD, FAPA, FAAP         
Sponsors and Collaborators
Genomind, LLC
Investigators
Study Director: Rachel Dicker, PharmD Genomind, LLC
  More Information

No publications provided

Responsible Party: Genomind, LLC
ClinicalTrials.gov Identifier: NCT01426516     History of Changes
Other Study ID Numbers: AG1-0001/2
Study First Received: August 29, 2011
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genomind, LLC:
Treatment Resistant
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014