Trial Outcomes & Findings for Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1) (NCT NCT01426516)

NCT ID: NCT01426516

Last Updated: 2021-09-13

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-09-13

Participant Flow

Participant milestones

Measure	Treatment as Usual (TAU) Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.	Genecept Assay Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account. Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
Overall Study STARTED	12	17
Overall Study COMPLETED	12	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment as Usual (TAU) n=12 Participants Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.	Genecept Assay n=17 Participants Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account. Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	17 Participants n=4 Participants	29 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	44 Years n=93 Participants	46 Years n=4 Participants	45 Years n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	17 Participants n=4 Participants	28 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Invalid Data Collection

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week

Population: Invalid data collection

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3, 6 months

Population: Invalid data collection

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: invalid data collection

To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: invalid data collection

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

Outcome measures

Outcome data not reported

Adverse Events

Treatment as Usual (TAU)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Genecept Assay

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment as Usual (TAU) n=12 participants at risk Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.	Genecept Assay n=17 participants at risk Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account. Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
Psychiatric disorders Minor to Moderate Adverse Effects to Medications	25.0% 3/12	35.3% 6/17

Additional Information

Dr. Rachel Scott

Genomind

Phone: 267-989-3435

Email: rscott@genomind.com

Results disclosure agreements

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