What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs (e.g., sertraline, fluoxetine), SNRIs (e.g., venlafaxine, duloxetine), and tricyclic antidepressants (e.g., amitriptyline, imipramine), are associated with a range of side effects. SSRIs often cause nausea, insomnia, sexual dysfunction, and weight gain. SNRIs can lead to similar side effects, including increased blood pressure and heart rate. Tricyclic antidepressants are known for causing dry mouth, constipation, urinary retention, and dizziness. Tailoring antidepressant therapy based on genetic variations aims to minimize these side effects by optimizing drug selection and dosing according to individual metabolic profiles.

What prior FDA approvals exist?

The FDA has approved several antidepressants for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, and citalopram, as well as serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine and duloxetine. Tricyclic antidepressants (TCAs) such as imipramine and desipramine have also been approved. These medications are relevant to the trial studying pharmacogenetic testing and genotype-guided therapy, as genetic variations can significantly affect their metabolism and efficacy. The goal of such tailored therapy is to optimize treatment outcomes by considering individual genetic profiles.

What other types of research exist?

<ol> <li>L-Methylfolate Supplementation: As a monotherapy for treatment-resistant depression, L-Methylfolate has shown promise in patients who do not respond to traditional antidepressants. It works by enhancing the synthesis of neurotransmitters involved in mood regulation.</li> <li>Inflammatory Biomarker-Guided Therapy: Using biomarkers to predict the outcome of depression treatment with specific antidepressants like escitalopram and nortriptyline can help tailor treatments more effectively.</li> <li>Cognitive-Behavioral Therapy (CBT): Especially in combination with pharmacotherapy, CBT has been effective in preventing relapse and improving outcomes in depression.</li> <li>Sequential Treatment Approaches: Combining initial pharmacotherapy with subsequent relapse-prevention strategies, such as CBT, can enhance long-term treatment outcomes.</li> <li>Advanced Psychotherapy Techniques: Techniques like mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT) are gaining traction for their effectiveness in treating depression.</li> </ol>

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Clinical Decision Support

Pharmacogenetic-Guided Treatment for Depression (ADOPT PGx Trial)

N/A

Waitlist Available

Led By Hrishikesh Chakraborty

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial helps doctors choose the best treatment for patients with depression by understanding how their bodies process medication, potentially improving symptoms more quickly.

Who is the study for?

This trial is for English or Spanish speakers aged 8 years and above with depression, who are starting or changing SSRI therapy at participating clinics. They must have had depressive symptoms for at least 3 months. Excluded are those too ill to consent, planning to move soon, with bipolar disorder, seizure disorders, certain genetic test results, psychosis, dementia or cognitive disabilities.

What is being tested?

The Depression Trial compares immediate pharmacogenetic testing and tailored anti-depressant therapy against standard care with delayed testing. It aims to see if personalized treatment based on how a person's body processes SSRIs can better reduce depression symptoms.

What are the potential side effects?

While the trial description does not specify side effects of interventions directly since it involves standard care practices and genetic testing which typically do not involve medication side effects; however general SSRI side effects may include nausea, sleep issues, agitation or anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3 Month Depression Symptom Control Change from Baseline

Secondary study objectives

3 Month Change in PHQ of Depression Symptomatology Change from Baseline Scores

3 Month Medication Adherence Change from Baseline

3 Month Medication Side Effect Burden Change from Baseline

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Depression - Immediate PGx TestingExperimental Treatment2 Interventions

Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider

Group II: Depression - Delayed PGx TestingExperimental Treatment1 Intervention

Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as SSRIs, SNRIs, and TCAs, work by altering neurotransmitter levels in the brain to improve mood and emotional state. The pharmacogenetic approach, as studied in the trial, involves tailoring these treatments based on individual genetic profiles that affect drug metabolism. This personalized method aims to enhance the efficacy and safety of antidepressant therapy, potentially leading to better outcomes and fewer side effects for patients.

Drugs: guide and caveats to explanatory and descriptive approaches--II. Drugs in psychiatric research.

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,424 Previous Clinical Trials

3,064,623 Total Patients Enrolled

75 Trials studying Depression

32,794 Patients Enrolled for Depression

National Human Genome Research Institute (NHGRI)NIH

266 Previous Clinical Trials

291,411 Total Patients Enrolled

Hrishikesh ChakrabortyPrincipal InvestigatorDuke University

4 Previous Clinical Trials

13,515 Total Patients Enrolled

1 Trials studying Depression

4,111 Patients Enrolled for Depression

Media Library

Clinical decision support (Clinical Decision Support) Clinical Trial Eligibility Overview. Trial Name: NCT05966155 — N/A

Depression Research Study Groups: Depression - Immediate PGx Testing, Depression - Delayed PGx Testing

Depression Clinical Trial 2023: Clinical decision support Highlights & Side Effects. Trial Name: NCT05966155 — N/A

Clinical decision support (Clinical Decision Support) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05966155 — N/A

~358 spots leftby Sep 2025

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