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Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

Primary Purpose

Depression, Anxiety, Generalized Anxiety Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DNA-guided choice of therapy
Clinical management
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DNA-guided choice of therapy

Clinical management

Arm Description

DNA-guided choice of antidepressant therapy

Clinical management

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale
Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale. FACT-G is a quality of life questionnaire with values ranging from 0 (not at all) to 4 (very much). The categories of measure are physical, social/family, emotional and functional well-being.

Full Information

First Posted
September 12, 2018
Last Updated
June 30, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03674138
Brief Title
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
Official Title
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
October 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Generalized Anxiety Disorder, Depressive Disorder, Major Depressive Disorder, Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DNA-guided choice of therapy
Arm Type
Active Comparator
Arm Description
DNA-guided choice of antidepressant therapy
Arm Title
Clinical management
Arm Type
Active Comparator
Arm Description
Clinical management
Intervention Type
Diagnostic Test
Intervention Name(s)
DNA-guided choice of therapy
Intervention Description
Buccal swab for DNA genotyping to identify best antidepressant therapy
Intervention Type
Other
Intervention Name(s)
Clinical management
Intervention Description
Clinical management to identify best antidepressant therapy
Primary Outcome Measure Information:
Title
Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Description
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
Time Frame
Baseline, week 12, month 12
Title
Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Description
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
Time Frame
Baseline, week 12, month 12
Secondary Outcome Measure Information:
Title
Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale
Description
Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale. FACT-G is a quality of life questionnaire with values ranging from 0 (not at all) to 4 (very much). The categories of measure are physical, social/family, emotional and functional well-being.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Hicks, PharmD, PhD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Links:
URL
http://moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials Website

Learn more about this trial

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

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