Clinical Study Evaluating Effects of Pharmacogenetic-guided vs Standard-of-Care Treatment on Depression and/or Anxiety

Depression Clinical Trial

Official title:

A Prospective, Multi-Center, Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetic-Guided Treatment for Depression & Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878928
• Other study ID #: CLP-0009
• Status: Completed
• Phase: N/A
• First received: July 14, 2016
• Last updated: December 16, 2016
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: AltheaDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A prospective, multi-center, randomized, subject and outcome evaluator blind , parallel-group study evaluating the effect of pharmacogenetic-guided versus standard of care treatment for subjects diagnosed with depression and/or anxiety disorders.

Description:

A substantial number of patients taking anti-depressant and anti-anxiety medications suffer from either a lack of benefit from drug therapy or severe side effects. Clinical features often fail to predict the drug response and tolerability of a patient to a prescription medication. Genetics can help guide therapeutic decisions for patients exhibiting neuropsychiatric disorders and potentially improve patient outcomes by maximizing drug efficacy and minimizing the risk of adverse events. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.

This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment. Pharmacogenetic-guided therapy selection using the IDgenetix Neuropsychiatric Test Panel can enhance patient response and tolerability by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.

In this prospective, multi-center, randomized, subject and outcome evaluator blind, parallel-group study patients presenting to the clinical site with evidence of depression and/or anxiety as determined by a qualified clinician will be invited to participate. Study participants will be randomized to one of two groups with respect to the IDgenetix Neuropsychiatric Test Panel result: group with testing results revealed to the medical provider prior to treatment selection (Experimental Group) or group without testing results prior to treatment selection (Control Group). Participant outcomes will be measured at baseline and throughout the 3-month duration of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects 18 years of age or older.

• Subjects diagnosed with depression and/or anxiety as per the DSM-V criteria or standard of care site procedures and meeting at least one of the following:

• Diagnosed with depression and/or anxiety either new to treatment or currently taking medications for less than 6 weeks.

• Inadequately controlled with medications defined as inadequate efficacy after 6 weeks of a psychotropic treatment or have discontinued psychotropic treatment due to adverse events or intolerability.

• Willing and able to comply with study procedures.

• Able to provide written informed consent.

Exclusion Criteria

• Unwilling or unable to provide written informed consent and to comply with study procedures.

• Any patient for whom providing a buccal swab sample would be contraindicated or not possible.

• Subjects diagnosed as not having anxiety or depression.

• Patients at significant risk for suicide and/or in need of immediate hospitalization as judged by the investigator.

• Diagnosis of Bipolar Disorder, as assessed by patient history or M.I.N.I. response.

• Diagnosis of Schizophrenia or Schizoaffective disorder, as assessed by patient history or M.I.N.I. response.

• History or diagnosis of a personality disorder, as assessed by patient history or M.I.N.I. response.

• History of physical traumatic injury (i.e., TBI) resulting in depression.

• Patients new to psychotherapy (provided by licensed and trained mental health professionals) or have not been on a stable psychotherapy regimen for at least 8 weeks.

• Patients receiving other alternative treatments such as Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS), Vagal Nerve Stimulation (VNS), and Deep Brain Stimulation (DBS).

• Patients with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5).

• Patients with abnormal hepatic function within the last 2 years, (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis).

• Patients with a history of malabsorption (short gut syndrome).

• Patients with any gastric or small bowel surgery less than 3 months prior to study enrollment.

• Patients with significant unstable medical condition, neurological disorders (e.g. epilepsy, Parkinson's disease or stroke) or life threatening disease.

• Patients who are currently being treated for anxiety and /or depression incorporating pharmacogenetic information.

• History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months.

• Patients with any significant substance use disorder as assessed by M.I.N.I. response and judged by the investigator.

• Pregnant or lactating women.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Genetic:
• IDgenetix Neuropsychiatric Test Panel
The IDgenetix Neuropsychiatric Test Panel is used to make recommendations on the medication therapy that might be impacted by the genetic background of the patient.

Locations

Country	Name	City	State
United States	United Medical Associates	Binghamton	New York
United States	Relaro Medical Trials	Dallas	Texas
United States	iResearch Atlanta	Decatur	Georgia
United States	Detweiler Family Medicine	Lansdale	Pennsylvania
United States	Innovative Clinical Research	Lauderhill	Florida
United States	Medpharmics	Metairie	Louisiana
United States	Innova Clinical Trials	Miami	Florida
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	APG Research	Orlando	Florida
United States	Carolina Partners in Mental HealthCare	Raleigh	North Carolina
United States	Adnab Research	Rolling Hills	California
United States	Artemis Clinical Research	San Diego	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Adnab Research	Torrance	California
United States	Collaborative Neuroscience Network	Torrance	California
United States	Tidewater Clinical Research	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
AltheaDx	Innovis LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction of adverse drug events (ADE) subsequent to pharmacogenetics-guided treatment as compared to standard of care for treatment of depression and/or anxiety symptoms.		12 weeks	No
Secondary	Change in the Hamilton Rating Scale for Depression (HAMD-17) score from baseline.		12 weeks	No
Secondary	Change in the Hamilton Rating Scale for Anxiety (HAM-A) score from baseline.		12 weeks	No
Secondary	Percentage of depression subjects who respond (=50% decrease in HAM-D17 from baseline or remit, HAM-D17 total score =7).		12 weeks	No
Secondary	Percentage of anxiety subjects who respond (=50% decrease in HAM-A from baseline or remit, HAM-A total score =7)		12 weeks	No
Secondary	Time to response/remission of depressive symptoms.		12 weeks	No
Secondary	Time to response/remission of anxiety symptoms.		12 weeks	No
Secondary	Medication change: Number of subjects who changed their antidepressant and anxiety medication regimens from baseline.		12 weeks	No
Secondary	The impact of pharmacogenetic-guided treatment.care costs as measured by HMWDQ		12 weeks	No