An Open Label Study of the Genecept™ Assay in Treatment Resistant Depression

• Efficacy [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Clinical Global Impressions (CGI) scale at 3 months.
  
  

• Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Quick Inventory of Depressive Symptoms (QIDS-SR1), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months.
  
  
• Medication Adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  To compare medication adherence between Patient subjects and matched control cohort
  
  
• Resource Utilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  To determine the comparative effectiveness of AGT versus Treatment as Usual (TAU) in a matched control cohort in outpatient management of nonpsychotic Major Depressive Disorder patients with treatment resistant depression, as measured by total claims.
  
  
• Impact of Specific Genetic Variants [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  1. To explore genetic variants within the patient population and identify subgroups for whom pharmacogenetic testing is particularly informative
  2. To determine which specific results of pharmacogenetic testing have the most impact on clinician behavior
  
  
• Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  To explore genetic variants in relationship to classes of medications and treatment response as measured by CGI and QIDs, and change in reported adverse events using the UKU (The Udvalg for Kliniske Undersøgelser Side Effect Rating Scale.)
  
  

Genomind is sponsoring an open label study of Assay Guided Treatment (AGT) using the Genecept Assay in adult outpatients with Treatment Resistant Major Depressive Disorder. The Genecept Assay is a Clinical Laboratory Improvement Amendments (CLIA) laboratory validated test being researched to determine if having information about genetic variations impacts patient outcomes.

The proposed investigation will examine the potential impact of the Assay in terms of depression severity as measured by change in CGI scale at 3 months. Secondary measures will assess change in Quick Inventory of Depressive Symptoms (QIDS-SR), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months. Additional measures include change in clinician treatment and diagnosis decisions and impact on mediation side effects using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU). Participant data will be compared to a matched control cohort to assess the impact of the use of the Genecept Assay on medication adherence and total claims.

Patients with a diagnosis of non-psychotic Major Depressive Disorder will be identified. These patients and their treating clinicians will be recruited. The present study proposes to enroll 1. Subjects (patients who are identified as eligible) and 2. Clinician study participants (clinicians who are identified as responsible for the care of eligible patients). This study will involve the collection of responses from both Subjects and clinician study participants with the intention of correlating this information to Subject genetic data.

Potential subjects and study participants will consent electronically on a secure study portal. Patients and Clinicians must both consent to participate in order to proceed in the study. After both subjects and clinician study participants have consent to participate, they will each be asked to complete an electronic baseline survey. Once the baseline survey is completed, the clinician will receive the Genecept Assay by mail and will then supervise collection of a saliva DNA sample during a routine office visit.

At baseline, month 1 and month 3, patient Subjects will be prompted to complete surveys which include questions about their psychiatric symptoms, quality of life and medication side effects. The 3 month patient assessment will also include a satisfaction questionnaire.

At baseline, clinician study participants will be prompted to complete a brief survey containing questions about the patient's psychiatric history and severity of illness, current treatment regimen and the treatment intentions of the clinician prior to receiving genetic results. After receiving the results of the Assay, clinician study participants will again be prompted to complete an online study survey containing questions related to the impact of the Genecept Assay on treatment and diagnosis decisions. The subject will continue with treatment as determined by the clinician study participant. At 3 months from baseline, clinician study participants will again be asked to complete an online survey with additional questions related to subsequent changes to the patient's treatment regimen and illness severity since receiving/implementing the results of the Assay.