A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management Of Depression (MOD)
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ClinicalTrials.gov Identifier: NCT02189057 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : October 22, 2018
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Condition or disease | Intervention/treatment | Phase |
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Depression Mood Disorder Bipolar | Other: AssureRx GeneSight genotyping results Other: Treatment as usual | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Subjects will be randomized to either genotyping intervention or treatment as usual. |
Masking: | Double (Participant, Investigator) |
Masking Description: | Subject and study staff will be blind to randomization. |
Primary Purpose: | Treatment |
Official Title: | A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression |
Actual Study Start Date : | November 2014 |
Actual Primary Completion Date : | October 19, 2018 |
Actual Study Completion Date : | October 19, 2018 |

Arm | Intervention/treatment |
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Experimental: GeneSight guided treatment
GeneSight guided group will have their research psychiatrist make treatment recommendations based on AssureRx GeneSight genotyping results.
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Other: AssureRx GeneSight genotyping results |
Active Comparator: Treatment as usual group
Treatment as usual group will have treatment recommendations based on clinical judgment
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Other: Treatment as usual |
- Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16) [ Time Frame: baseline, 8 weeks ]The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.
- Number of subjects with improvement of depressive symptoms as shown by 50% reduction in QIDS-C16 score [ Time Frame: 8 weeks ]The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.
- Number of subjects with improvement of depressive symptoms as shown by a score <6 on QIDS-C16 [ Time Frame: 8 weeks ]The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.
- Number of subjects with improvement of depressive symptoms as shown by score of "much" or "very much improved" on Clinical Global Impression - Improvement Scale [ Time Frame: 8 weeks ]The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved, 2. Much improved, 3. Minimally improved, 4. No change, 5. Minimally worse, 6. Much worse, 7. Very much worse
- Improvement of depressive symptoms as shown by the Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: 8 weeks ]The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.
- Improvement of depressive symptoms [ Time Frame: 8 weeks ]Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-65, male or female, any race/ethnicity
- Mayo Clinic Depression Center inpatient or outpatient, or an outpatient of Mayo Clinic Rochester and satellite clinics, and outpatients from Mayo Clinic Health System clinics
- Ability to provide informed consent
- Structured Clinical Interview (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 [8]
- Current index episode having not been treated with psychotropic medications or inadequately responsive to treatment (IRT). IRT defined as intolerability, adverse event, or inadequate efficacy of current psychotropic medication (at least 4 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 serum or urine pregnancy test (or history of hysterectomy)
- Negative urine toxicology test (will only be completed at the request of the treating clinician).
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 & baseline visit with exception of no more than 8mg of Ativan within a 24-hour period.
- Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for any significant current substance use disorder other than nicotine or caffeine. Must have at least early, partial or full, remission X 3 months
- Clinically diagnosed cannabis use disorder, or SCID confirmed cannabis abuse or dependence.
- 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 upper limit of normal (ULN) for Aspartate Aminotransferase (AST) or Alanine Aminotransferase (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
- Known cytochrome (CYP) & serotonin transporter genomic testing results within 5 years
- A score of ≥15 on the Young Mania Rating Scale (YMRS)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189057
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Mark Frye, MD | Mayo Clinic |
Responsible Party: | Mark Frye, Chair-Psychiatry/Psychology, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT02189057 |
Other Study ID Numbers: |
13-007981 |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | October 22, 2018 |
Last Verified: | October 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bipolar Unipolar Genotyping Pharmacokinetic Pharmacodynamic |
Depression Depressive Disorder Mood Disorders Behavioral Symptoms Mental Disorders |