NCT03674138

Brief Summary

This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2021

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2024

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

September 12, 2018

Last Update Submit

February 4, 2026

Conditions

AnxietyDepressive DisorderMajor Depressive DisorderCancerDepressionGeneralized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

  • Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)

    The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).

    Baseline, week 12, month 12

  • Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)

    The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).

    Baseline, week 12, month 12

Secondary Outcomes (1)

  • Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale

    12 months

Study Arms (2)

DNA-guided choice of therapy

ACTIVE COMPARATOR

DNA-guided choice of antidepressant therapy

Diagnostic Test: DNA-guided choice of therapy

Clinical management

ACTIVE COMPARATOR

Clinical management

Diagnostic Test: DNA-guided choice of therapyOther: Clinical management

Interventions

DNA-guided choice of therapyDIAGNOSTIC_TEST

Buccal swab for DNA genotyping to identify best antidepressant therapy

Clinical managementDNA-guided choice of therapy
Clinical managementOTHER

Clinical management to identify best antidepressant therapy

Clinical management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a cancer diagnosis
  • Be 18 years of age or older
  • Patients who rate depression or anxiety \> 5 based on a 10 point scale
  • Patients expected to live greater than 6 months
  • Serum bilirubin and creatinine \< 1.5x upper limit of normal
  • AST and ALT \< 3 times upper limit of normal
  • Willing and able to provide written informed consent
  • Able to complete self-assessment questionnaires

You may not qualify if:

  • Patients not diagnosed with cancer
  • Antidepressant prescribing performed by a non-Moffitt psychiatrist after enrollment onto the clinical trial
  • Known Pregnancy
  • History of liver or allogenic stem cell transplant
  • Patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersGeneralized Anxiety DisorderDepressive DisorderDepressive Disorder, MajorNeoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersMood Disorders

Study Officials

  • James K Hicks, PharmD, PhD

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be blinded to the genomic results for 12 weeks, with the 12 week time period starting at the time of antidepressant drug prescribing.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 17, 2018

Study Start

September 12, 2018

Primary Completion

September 3, 2021

Study Completion

October 27, 2024

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)