DepressionNCT03674138
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
A study testing DNA-guided choice of therapy and Clinical management in people with Depression and Anxiety, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Generalized Anxiety Disorder
- What is being tested?
- DNA-guided choice of therapy and Clinical management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2018to 27 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
- Conditions
- Depression, Anxiety, Generalized Anxiety Disorder, Depressive Disorder, Major Depressive Disorder, Cancer
- Being tested
- DNA-guided choice of therapy, Clinical management
- Medical subject headings
- Depression, Anxiety Disorders, Generalized Anxiety Disorder, Depressive Disorder, Depressive Disorder, Major, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA-guided choice of therapyDiagnostic test
Buccal swab for DNA genotyping to identify best antidepressant therapy
Clinical managementOther
Clinical management to identify best antidepressant therapy
| Study group | Role | What they receive |
|---|---|---|
| DNA-guided choice of therapy | Active comparator | DNA-guided choice of antidepressant therapy Receives: Diagnostic Test: DNA-guided choice of therapy |
| Clinical management | Active comparator | Clinical management Receives: Diagnostic Test: DNA-guided choice of therapy; Other: Clinical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline, week 12, month 12
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start12 Sep 2018
- Primary completion3 Sep 2021
- Study completion27 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James K Hicks, PharmD, PhD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674138
- Sponsor's protocol ID
- MCC-19578
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2018
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
- ClinicalTrials.gov ID
- NCT03674138
- Acronym / sponsor ID
- MCC-19578
- Conditions
- Depression, Anxiety, Generalized Anxiety Disorder, Depressive Disorder, Major Depressive Disorder, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNA-guided choice of therapy | Active comparator | Diagnostic Test: DNA-guided choice of therapyDNA-guided choice of antidepressant therapy |
| Clinical management | Active comparator | Diagnostic Test: DNA-guided choice of therapy, Other: Clinical managementClinical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA-guided choice of therapyBuccal swab for DNA genotyping to identify best antidepressant therapy | Diagnostic test | Clinical management, DNA-guided choice of therapy |
| Clinical managementClinical management to identify best antidepressant therapy | Other | Clinical management |
Primary outcome
Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, week 12, month 12
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)
Time frame: Baseline, week 12, month 12
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
1 secondary outcome
Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James K Hicks, PharmD, PhD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA-guided choice of therapy and Clinical management in people with Depression and Anxiety, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline, week 12, month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.