Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)

NCT01426516 | Terminated Results DMC

• 1 other identifier: AG1-0001/2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials. Such treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs of MDD, in terms of health care costs, functional impairment, and diminished quality of life. The promise of personalized medicine for individuals at high risk for TRD is apparent. If these individuals could be recognized early in their disease course, they could be triaged to more intensive or targeted interventions to improve their likelihood of remission. With the proliferation of treatment options in MDD, at present individuals can spend months or years in and out of treatment before receiving these next-step treatments. At present, no clinical or biomarker-based tool has been shown to assist in matching patients with treatments most likely to be effective for them. The Genecept Assay offers the possibility of "Personalized Medicine" in psychiatry. Clinicians may find this additional genetic information can lead to optimized treatment plans for individual patients. Before such an assay can be widely applied clinically, it is necessary to demonstrate that this tool usefully impacts treatment outcomes. This study will examine the potential impact of the assay in terms of depression severity at 3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate of its potential to change clinician behavior and improve patient quality of life. Further measures will also allow for refinement of the assay to maximize patient and clinician satisfaction, and estimate the potential savings associated with deployment of this assay in real-world clinical settings.

Conditions

Major Depressive Disorder

Keywords

Treatment Resistant; Depression

Outcome Measures

Primary Outcomes (1)

• Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months

  To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months Add: * highest score on any 1 of the 4 sleep items (items 1 to 4) * highest score on any 1 of the 4 weight items (items 6 to 9) * highest score on either of the 2 psychomotor items (15 and 16) * scores for each of the 6 MDD symptom domains Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression

  6 months

Secondary Outcomes (4)

• Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.

  one week

• Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)

  baseline, 3, 6 months

• Cost

  6 months

• Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey

  6 months

Study Arms (2)

Treatment as usual (TAU)

NO INTERVENTION

Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.

Genecept Assay

EXPERIMENTAL

Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.

Device: Genecept Assay

Interventions

Genecept Assay DEVICE

Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders

Also known as: Genetic Test

Genecept Assay

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65
• written informed consent
• diagnosis of non-psychotic major depression as determined by study
• clinician/current medical prescriber, and mood disorder diagnosis confirmed by PHQ-9
• QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
• failure of at least 1 prior adequate trial of a standard antidepressant (by ATRQ criteria - i.e., 6 weeks at adequate dose)

You may not qualify if:

• psychotic features in the current episode, based upon clinical assessment
• or more failed pharmacologic interventions in the current major depressive episode \[response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects\]
• current substance use disorder other than nicotine which based upon clinical assessment requires inpatient or outpatient detoxification
• pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
• women who are breastfeeding
• serious suicide or homicide risk, as assessed by evaluating clinician
• other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests
• patients who have taken an investigational psychotropic drug within the last 3 months

Sponsors & Collaborators

• Genomind, LLC: lead

Study Sites (1)

Centerstone

Nashville, Tennessee, 37228, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Rachel Scott
• Organization: Genomind

rscott@genomind.com

267-989-3435

Study Officials

• Rachel Dicker, PharmD

  Genomind, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 13, 2021
• Results First Posted: November 30, 2015

Record last verified: 2021-08

Locations

US (1)