Behaviors and Mental Disorders

All Conditions

Depression

Anxiety Disorders

Depressive Disorder

Depressive Disorder, Major

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Mood Disorders

Psychotropic Drugs

All Drugs and Chemicals

Antidepressive Agents

DNA-guided choice of antidepressant therapy

Buccal swab for DNA genotyping to identify best antidepressant therapy

DNA-guided choice of therapy

Clinical management to identify best antidepressant therapy

Clinical management

James K Hicks, PharmD, PhD

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.

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.

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

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

H. Lee Moffitt Cancer Center and Research Institute

Neoplasms

Symptoms and General Pathology

Head and Neck Neoplasms

Pain

Vasoconstrictor Agents

Norepinephrine

Venlafaxine Hydrochloride

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Starting dose of oral venlafaxine immediate release (IR) 37.5 mg BID, to be taken with food. The dosing will be increased at a rate of 75mg per week for 3 weeks, to reach a desired dose of 300mg per day, taken as 150mg BID.

For patients with hepatic impairment, severe renal impairment, or end-stage kidney disease, the starting dose is 37.5 mg once daily, and the dose is increased by increments of 37.5 mg per day, to a maximum of 187.5 mg per day, taken as 93.75 mg BID.

No intervention will be provided for this group

The Immediate Release generic formulation of this drug will be used due to its ability to be crushed for those patients who rely on parenteral administration of medications.

Venlafaxine

Jessica Grayson, MD

The purpose of this research study is to initiate a pharmacotherapy protocol for at-risk patients with newly diagnosed head and neck cancer in order to decrease the incidence of anxiety, depression, and uncontrolled pain during cancer treatment.

Patients requiring treatment of his or her newly diagnosed mucosal or cutaneous head and neck cancer per standard of care guidelines that meet all enrollment criteria will be identified and enrolled after obtaining informed consent. This will occur in the clinic setting, and subsequent screening and work up will be performed.

Enrolled patients will be randomized into one of the two study groups (Treatment v Control) via a computer-based program.

Treatment Group: Participants will be prescribed a starting dose of venlafaxine immediate release (IR) 37.5 mg twice daily. The IR formulation was selected due to its ability to be crushed for those patients who rely on parenteral administration of medications. The dosing will be increased at a rate of 75mg per week, to reach a desired dose of 300mg, divided into 150mg BID dosing. This dosing was selected due to the need for at least 150mg to see noradrenergic effects. For patients with hepatic impairment, severe renal impairment, or end-stage kidney disease, the starting dose is 37.5 mg once daily, and the dose is increased by increments of 37.5 mg per day, to a maximum of 187.5 mg per day, given in two divided doses.

Control Group: Participants will not receive any pharmacological treatment.

Patients in the Treatment Group will meet with a dedicated research collaborator via telephone on a weekly visit (for a maximum of 3 visits) as the medication is being titrated up to ensure tolerability. If at any point there are side effects or concerns regarding tolerability of medication, a collaborating psychiatrist who specializes in treatment of depression is available for consultation.

Patients in both groups will follow up 6-8 weeks after beginning their chosen treatment regimen for their HNC as determined for them by their standard of care evaluation. They will complete all of the study questionnaires at this visit. Vital signs will be collected at this visit as well as concomitant medications and any adverse events they may be experiencing.

Follow-up visits will continue every three months following this visit per the patient's standard of care return to clinic visits. It is anticipated that participants will be seen in clinic during Months 6, 9, and 12 as follow up for their standard of care treatment regimen. Vital signs, concomitant medications, adverse events, and responses to questionnaires will be collected at these visits.

Participant duration will be up to one year. If at any point, patients meet criteria for MDD, they will be referred to a mental health counselor.

Mood Disorders in Head and Neck Cancer Patients

Serotonin-Norepinephrine Reuptake Inhibitors for the Prevention and Treatment of Pain, Depression, and Anxiety in Patients With Head & Neck Cancer

The degree of depression in patients who currently do not show signs of depression at the beginning of undergoing HNC treatment. This will be assessed using the following validated questionnaires: Patient-Health Questionnaire (PHQ-9) and the Quick Inventory of Depressive Symptomatology (QIDS SR-16). For both questionnaires, an increase in score is considered to show a higher degree of depression.

University of Alabama at Birmingham

Principal Investigator

Cardiotonic Agents

Bupropion

Selective Serotonin Reuptake Inhibitors

Antidepressive Agents, Tricyclic

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Serotonin Receptor Agonists

All new users of antidepressants January 1, 1996 through December 31, 2006. Individuals 18 years of age or older with medical and pharmacy benefits and at least 6 months of health plan enrollment before the first antidepressant prescription.

Regular use of bupropion is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

Regular bupropion use

Regular use of SSRI is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

Regular SSRI (Selective serotonin reuptake inhibitors) use

Regular use of TCA is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

Regular TCA (Tricyclic antidepressants) use

Regular use of any other antidepressants is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date. An "other antidepressant" would be any antidepressant other than bupropion, a SSRI or a TCA.

Regular use of any other antidepressant

GSK Clinical Trials

There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Carcinogenicity Study of Bupropion

Post-marketing Carcinogenicity Study of Bupropion

The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

GlaxoSmithKline

This is a retrospective study of pre-existing data; thus, no assessments for Serious or Non-serious Adverse Events were performed.

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases

New Antidepressant Exposure in Colorectal Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls

New Antidepressant Exposure in Colorectal Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases

New Antidepressant Exposure in Lung Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls

New Antidepressant Exposure in Lung Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases

New Antidepressant Exposure in Bladder Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls

New Antidepressant Exposure in Bladder Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases

New Antidepressant Exposure in Uterine Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls

New Antidepressant Exposure in Uterine Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases

New Antidepressant Exposure in Breast Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls

New Antidepressant Exposure in Breast Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases

New Antidepressant Exposure in Prostate Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls

New Antidepressant Exposure in Prostate Cancer: Controls

Total

45-54 years

55-64 years

65-74 years

>=75 years

Age, Customized

Sex: Female, Male

Exposed to multiple antidepressants

Ever smokers

Unknown smoking status

Ever diagnosed (dx) with depression

Ever dx with inflammatory bowel disease (IBD)

Users of oral contraceptives (OC)

Users of hormone replacement therapy (HRT)

Users of NSAIDs

A value of "0" indicates that no data are available for that particular treatment arm. Smoking status data were not collected for breast cancer and prostate cancer cases and controls, as it is not a necessary variable for analysis. NSAIDS, non-steroidal anti-inflammatory drugs.

Number of participants diagnosed with the indicated conditions and using the indicated therapies

GSK Response Center

Cases

Controls

Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date

Bupropion, Regular Use

Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date

All Non-bupropion Antidepressants, Regular Use

Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date

Tricyclic Antidepressants (TCA), Regular Use

Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date

Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use

Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date

Other Antidepressants, Regular Use

Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users

Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant

Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date

Regular 'other' antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date

Participants diagnosed with colorectal cancer who were new antidepressant users.

Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with lung cancer who were new antidepressant users.

Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with bladder cancer who were new antidepressant users.

Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with uterine cancer who were new antidepressant users.

Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with breast cancer who were new antidepressant users.

Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with prostate cancer who were new antidepressant users.

Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Antidepressant Exposure in Uterine Cancer: Cases

Overall Study

Blood and Lymph Conditions

Body Weight

Hematologic Diseases

5-week CBT-based mobile intervention for adolescents with depressive symptoms

5-week mobile control with education about depression

SparkRx is a 5-week program divided into levels intended to be completed weekly. SparkRx is a behavioral activation program. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and participant symptom check (PSC) in the mobile app. Tasks in the mobile app progress in a linear fashion (i.e., each task must be completed to progress to the next task).

CBT-based mobile intervention for depression

The control mobile application will consist of 5 weeks of educational content about depression. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app.

Mobile control with education about depression

Julie Germann, PhD.

The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).

The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).

These aims will be accomplished by evaluating:

* Feasibility of recruiting and enrolling adolescents with mild to severe symptoms of depression from specialty care medical programs at CHST.
* Retention, program adherence, completion, and withdrawal rates.
* Perceived utility, usability, and enjoyment of the program by adolescents
* Clinically significant changes between pre- to -post treatment and persistence of such gains at 1 month follow up.
* Preliminary evidence of efficacy defined as a statistically significant difference in the eight-item Patient Health Questionnaire (PHQ-8) scores (p \< 0.05) between Spark and an educational control at post-treatment.
* Safety of the intervention, including rates of reported adverse events and adverse device effects

Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management

Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management

Difference in the change in PHQ-8 scores between the SparkRx and control arms. Score range of 0 to 24 with higher scores indicating worse outcome.

Measured by the Generalized Anxiety Disorder scale (GAD-7).The GAD-7 is a brief 7-item assessment for generalized anxiety disorder with satisfactory sensitivity and specificity. Score range of 0 to 21 with a higher score indicating worse outcome.

Measured using the Short Form-36 (SF-36), a set of generic, coherent, self-reported, and easily administered quality-of-life measures used to routinely monitor and assess the care outcomes of participants. 8 subscales with scores ranging from 0-100, higher being a more favorable health state.

Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health

Measured using caregiver proxy measures of the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Measured using caregiver proxy measures of the SF-36. 8 subscales with scores ranging from 0-100, higher being a more favorable health state.

Measured using the Hope Scale, a 12-item self-report measure, which assesses dispositional hope in adults. Each item rated from 1-8 (definitely false - definitely true). Scores range from 8-64, with higher being more hopeful.

Subscales: agency and pathway.

Descriptive understanding of healthcare utilization. Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that assesses participants' use of healthcare resources.

Descriptive understanding of caregiver burden, measured by the work absenteeism questionnaire, containing questions about caregiving responsibilities and related impacts on employment. Higher scores indicate more hours missed per week of work.

Measured by the Functional Disability Inventory a fifteen-item questionnaire that measures functional disability and evaluates the impact of illness on the respondents' physical and psychosocial functioning in everyday social roles. Each question is rated on a 5-point scale from 0(No Trouble) to 4 (Impossible). Score range is 0 to 60 with higher scores indicating a worse outcome.

Measured by the User Experience (UXR) questionnaire. Includes questions from the Usability Metric for User Experience (UMUX)-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the Happiness Tracking Surveys (HaTs); an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.

Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Stanford Expectations of Treatment Scale (SETS), an instrument for measuring positive and negative treatment expectancies. There are two subscales, the positive and negative expectancy. Scores range from 1-7, with higher scores indicating greater positive and negative expectancy.

Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Credibility/Expectancy Questionnaire (CEQ), a questionnaire for measuring cognitively-based credibility and relatively more affectively-based expectancy of therapy outcomes. Scores range from 6-60, with higher scores indicating a greater expectation of treatment success.

Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome.

Percent of potential participants eligible to participate

Percent of eligible participants willing to participate

Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment

Adherence to program determined by average number of modules completed

Adherence to program determined by engagement with program (time spent in app)

Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome.

* Clinically significant improvement: reduction in assessment score \>= 5
* Treatment response: 50% reduction in symptoms from pre to post-intervention
* Remission is defined as a score \< 5

Rates of adverse events and adverse advice effects

Usability measured with the System Usability Scale (SUS), which consists of 10 items, each with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores meaning more usable.

Engagement measured with the User Engagement Scale - Short Form (UES-SF), which measures self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Scores range from 1-5, with higher scores indicating more engaging material.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients	NCT03674138	Depression Anxiety Generalized Anx... Depressive Diso... Major Depressiv... Cancer	DNA-guided choi... Clinical manage...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Mood Disorders in Head and Neck Cancer Patients	NCT04977271	Depressive Diso... Head and Neck C...	Venlafaxine	18 Years -	University of Alabama at Birmingham
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients	NCT03674138	Depression Anxiety Generalized Anx... Depressive Diso... Major Depressiv... Cancer	DNA-guided choi... Clinical manage...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Carcinogenicity Study of Bupropion	NCT01077596	Depressive Diso... Cancer	Regular bupropi... Regular SSRI (S... Regular TCA (Tr... Regular use of ...	18 Years -	GlaxoSmithKline
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients	NCT03674138	Depression Anxiety Generalized Anx... Depressive Diso... Major Depressiv... Cancer	DNA-guided choi... Clinical manage...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight Management	NCT05351866	Depression Depressive Diso... Depressive Symp... Depressive Epis... Adolescent Beha... Adolescent - Em... Hematologic Dis... Oncology Weight, Body	CBT-based mobil... Mobile control ...	13 Years - 22 Years	Limbix Health, Inc.
Carcinogenicity Study of Bupropion	NCT01077596	Depressive Diso... Cancer	Regular bupropi... Regular SSRI (S... Regular TCA (Tr... Regular use of ...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for depressive disorder