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Trial Outcomes & Findings for An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay (NCT NCT01507155)

NCT ID: NCT01507155

Last Updated: 2016-06-08

Results Overview

To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

685 participants

Primary outcome timeframe

3 months

Results posted on

2016-06-08

Participant Flow

Participant milestones

Participant milestones
Measure
Clincian-Reported Outcomes
Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing. Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Patient-Reported Measures
Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
Overall Study
STARTED
625
60
Overall Study
COMPLETED
625
60
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clinician-Reported Outcomes
n=625 Participants
Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing. Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Age, Continuous
40.5 years
n=5 Participants
Sex: Female, Male
Female
412 Participants
n=5 Participants
Sex: Female, Male
Male
213 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
25 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
600 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Current Smoker
Current Smoker
36 participants
n=5 Participants
Current Smoker
Not a smoker
227 participants
n=5 Participants
Current Smoker
Unknown
362 participants
n=5 Participants
Marital Status
Married
177 participants
n=5 Participants
Marital Status
Divorced/Separated
53 participants
n=5 Participants
Marital Status
Single
118 participants
n=5 Participants
Marital Status
Widowed
1 participants
n=5 Participants
Marital Status
Unknown
276 participants
n=5 Participants
Education
>College degree
145 participants
n=5 Participants
Education
Some college
140 participants
n=5 Participants
Education
High school diploma
50 participants
n=5 Participants
Education
No high school diploma
6 participants
n=5 Participants
Education
Unknown
284 participants
n=5 Participants
Employment Status
Full-time
182 participants
n=5 Participants
Employment Status
Part-time
39 participants
n=5 Participants
Employment Status
Unemployed/disabled/leave of absence
83 participants
n=5 Participants
Employment Status
Student
33 participants
n=5 Participants
Employment Status
Retired
12 participants
n=5 Participants
Employment Status
Unknown
276 participants
n=5 Participants
Annual Income
> $75,000
62 participants
n=5 Participants
Annual Income
$25,000-75,000
152 participants
n=5 Participants
Annual Income
< $25,000
135 participants
n=5 Participants
Annual Income
Unknown
276 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 months

To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).

Outcome measures

Outcome measures
Measure
Clinician's Utilizing Assay Guided Treatment in Psychiatry
n=625 Participants
Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing. Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months
CGI-I Score 1, 2, or 3
545 Participants
Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months
CGI-I Score 1 or 2
386 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Only 197 patients completed self-assessments at 3 months.

To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales: 1. Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression 2. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life 3. Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating 4. the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe

Outcome measures

Outcome measures
Measure
Clinician's Utilizing Assay Guided Treatment in Psychiatry
n=197 Participants
Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing. Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
Q-LES-Q-SF
50.0 Scores on a scale
Standard Deviation 1
Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
QIDS-SR16
7.8 Scores on a scale
Standard Deviation 0.75
Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
UKU: Side Effects
19.2 Scores on a scale
Standard Deviation 2
Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
SAS
35.9 Scores on a scale
Standard Deviation 0.5

Adverse Events

Clinician-Reported Outcomes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Patient-Reported Outcomes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Scott

Genomind

Phone: 267-989-3435

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place