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

Major Depressive Disorder Clinical Trial

— PAGE-1_AG1  

Official title:

A Six-month Study of the Genecept Assay vs. Treatment as Usual to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01426516
• Other study ID #: AG1-0001/2
• Status: Terminated
• Phase: N/A
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2021
• Source: Genomind, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• psychotic features in the current episode, based upon clinical assessment

• 4 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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Genecept Assay
Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders

Locations

Country	Name	City	State
United States	Centerstone	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Genomind, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.	Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.	one week
Secondary	Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)	To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.	baseline, 3, 6 months
Secondary	Cost	To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.	6 months
Secondary	Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey	To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder	6 months