A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression

Depression Clinical Trial

— AMOD  

Official title:

A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286440
• Other study ID #: 14-005547
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 6, 2019

Study information

• Verified date: June 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence

Description:

Treatment seeking adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform. This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. These patients will have GeneSight® testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection. In Group 2 (n=138), testing results will not be available to the patient's research treating clinician. However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The patients and the clinical raters will be blinded to group assignment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age 13-18, male or female, any race/ethnicity

• Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.

• Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)

• Ability to provide informed consent

Exclusion Criteria:

• Inability to speak English

• Inability or lack of willingness to provide informed consent and assent.

• Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.

• Psychotropic medication change (including dosage) between screening & randomization visits.

• Patients who meet DSM 5 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

• Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.

• Significant unstable medical condition.

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• AssureRx GeneSight genotyping results

• Treatment as usual

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline to endpoint change in depression	The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).	8 weeks
Secondary	Improvement of depressive symptoms	Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)	8 weeks
Secondary	Improvement of depressive symptoms	Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)	8 weeks
Secondary	Improvement of depressive symptoms	Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)	8 weeks
Secondary	Improvement of depressive symptoms	Clinical Global Impression (CGI) scale	8 weeks
Secondary	Improvement of depressive symptoms	Global Assessment Scale (CGAS)	8 weeks
Secondary	Improvement of depressive symptoms	General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form	8 weeks
Secondary	Improvement of depressive symptoms	Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention	8 weeks

External Links

•   Mayo Clinic Clinical Trials