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Trial record 2 of 5 for:    assurerx

A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management Of Depression (MOD)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Mayo Clinic
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic Identifier:
First received: July 8, 2014
Last updated: July 11, 2014
Last verified: July 2014

The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence.

Condition Intervention Phase
Mood Disorder
Other: AssureRx GeneSight genotyping results
Other: Treatment as usual
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Baseline to endpoint change in depression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure will be baseline to endpoint change in the Quick Inventory of Depressive Symptomatology (QIDS-C16).

Secondary Outcome Measures:
  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    QIDS-C16 response (50% reduction)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    QIDS-C16 remission (<6)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Clinical global impression (CGI) from preceding phase of "much" or "very much improved"

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Baseline to endpoint change in Hamilton Rating Scale for Depression (HAMD-17)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention.

Estimated Enrollment: 276
Study Start Date: July 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GeneSight guided treatment
GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results
Other: AssureRx GeneSight genotyping results
Active Comparator: Treatment as usual group
Treatment as usual group will have treatment recommendations based on clinical judgment
Other: Treatment as usual

Detailed Description:

Treatment seeking depressed patients (SCID confirmed major depressive disorder or bipolar I/II disorder) to the Mayo Clinic Depression Center will be invited to participate in this study evaluating the Assurex GeneSight® platform; this new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, antipsychotic, and stimulant associated treatment outcomes for depression. This study will recruit treatment seeking patients with major depression with an index episode of moderate symptom severity that has been unresponsive or poorly tolerated to at least one prior antidepressant treatment. This will be an 8-week, double-blind trial where depressed patients are randomized to testing results of GeneSight® (tricolored clinical report) prior to treatment selection (n=138) vs. treatment as usual (tricolored dummy report) (n=138). All testing results will be made available after the 8-week trial.


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

Inclusion Criteria:

  • Age 18-65, male or female, any race/ethnicity
  • Mayo Clinic Depression Center inpatient or outpatient
  • Ability to provide informed consent
  • SCID confirmed major depressive episode associated with Major Depressive Disorder, Bipolar I/II disorder, or Schizoaffective Bipolar Disorder
  • Current index episode of major depression < 2 years duration
  • Moderate symptom severity defined by HAMD-17 rating scale score ≥ 17
  • Current index episode inadequately responsive to treatment (IRT). IRT defined as discontinuation of one or more psychotropic treatments due to intolerability, adverse event, or inadequate efficacy (at least 6 weeks duration)
  • Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests
  • Negative urine toxicology screen
  • Negative serum or urine pregnancy test (or history of hysterectomy)

Exclusion Criteria:

  • Inability to speak English
  • Inability or lack of willingness to provide informed consent
  • Axis I or II disorder other than depression (i.e., by clinical assessment) that is the primary reason for treatment
  • Psychotropic medication change (including dosage) between screening & randomization
  • Patients who meet DSM-IV-TR criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months
  • Current clinical diagnosis delirium, dementia, other cognitive disorders, or non-mood psychotic disorder (i.e., schizophrenia, delusional disorder)
  • Index episode symptoms of hallucinations or delusions
  • Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator
  • History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months
  • Significant unstable medical condition
  • Hepatic insufficiency (2.5 X ULN for AST or ALT), past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver
  • Malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications
  • Participation in another clinical trial within 30 days of the screening visit
  • Anticipated inability to attend scheduled study visits
  • Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol
  • Cytochrome (CYP) & serotonin transporter genomic testing within 5 years
  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 identifier: NCT02189057

Contact: Scott E. Feeder 507-255-1975

United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Scott E. Feeder    507-255-1975   
Principal Investigator: Mark A. Frye, MD         
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark Frye, CHAIR-PSYCHIATRY/PSYCHOLOGY, Mayo Clinic Identifier: NCT02189057     History of Changes
Other Study ID Numbers: 13-007981
Study First Received: July 8, 2014
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders processed this record on November 25, 2014