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

NCT02189057 | Completed

• 1 other identifier: 13-007981
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Mood Disorder; Bipolar

Keywords

Bipolar; Unipolar; Genotyping; Pharmacokinetic; Pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)

  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.

  baseline, 8 weeks

Secondary Outcomes (5)

• Number of subjects with improvement of depressive symptoms as shown by 50% reduction in QIDS-C16 score

  8 weeks

• Number of subjects with improvement of depressive symptoms as shown by a score <6 on QIDS-C16

  8 weeks

• Number of subjects with improvement of depressive symptoms as shown by score of "much" or "very much improved" on Clinical Global Impression - Improvement Scale

  8 weeks

• Improvement of depressive symptoms as shown by the Hamilton Rating Scale for Depression (HAMD-17)

  8 weeks

• Improvement of depressive symptoms

  8 weeks

Study Arms (2)

GeneSight guided treatment

EXPERIMENTAL

GeneSight guided group will have their research psychiatrist make treatment recommendations based on AssureRx GeneSight genotyping results.

Other: AssureRx GeneSight genotyping results

Treatment as usual group

ACTIVE COMPARATOR

Treatment as usual group will have treatment recommendations based on clinical judgment

Other: Treatment as usual

Interventions

AssureRx GeneSight genotyping results OTHER

GeneSight guided treatment

Treatment as usual OTHER

Treatment as usual group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Depression; Mood Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Mark Frye, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subject and study staff will be blind to randomization.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair-Psychiatry/Psychology

Model Details: Subjects will be randomized to either genotyping intervention or treatment as usual.

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 14, 2014
• Study Start: November 1, 2014
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

US (1)