Trial · NCT03170362

PRIME Care (PRecision Medicine In MEntal Health Care)

NCT03170362, Not applicable, Completed, VA Office of Research and Development; results first posted 2024-05-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PRIME Care (PRecision Medicine In MEntal Health Care). Trials, record NCT03170362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03170362

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PRIME Care (PRecision Medicine In MEntal Health Care)
NCT number: NCT03170362
Status: Completed
Phases: Not applicable
Enrollment: 1,944 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Major Depression
Interventions: Pharmacogenetic Test
First posted: 2017-05-31
Last updated: 2024-05-28
Results first posted: 2024-05-28

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Depression Remission	24 weeks post randomization	The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission was defined as a score of 5 or less at the endpoint. the reported number of participants are those reaching that threshold of symptoms.
Primary	Use of Fewer Medications That Have Potential Gene-drug Interactions	Over the first 30 days	The investigators will examine the proportion of antidepressants prescribed in the first 30 days of the trial that have the potential for gene-drug interactions. The chance for a gene-drug interaction was classified as 1. the subject did not have a prescription for an antidepressant during the initial 4 weeks of the trial (No Antidepressant), 2 the subject was prescribed an antidepressant with no known gene-drug interaction (No Gene Interaction), 3 the subject was prescribed an antidepressant with moderate gene-drug interactions (Moderate Interaction). These are also gene-drug interactions that do not have level A concordance. And 4. the subject was prescribed an antidepressant with substantial gene-drug interactions or gene-drug interactions that are considered to have a high level of evidence to support other prescribing.
Secondary	Depression Severity	24 Weeks	The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self-assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. This measure will use the PHQ9 as a continuous measure. The reported outcome is the difference in scores from baseline to 24 weeks.
Secondary	Depression Response	24 weeks	The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Response was measured by a 50% reduction in scores from baseline to each time point.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Depression Remission	24 weeks post randomization	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Use of Fewer Medications That Have Potential Gene-drug Interactions	Over the first 30 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Depression Severity	24 Weeks	units on a scale	MEAN
SECONDARY	Depression Response	24 weeks	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Depression Remission	Intervention Group		130	Participants
Depression Remission	Delay Results Group		126	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Intervention Group	No Antidepressant prescibed	239	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Delay Results Group	No Antidepressant prescibed	299	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Intervention Group	Taking an antidepressant with no gene interaction	433	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Delay Results Group	Taking an antidepressant with no gene interaction	173	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Intervention Group	Taking an antidepressant with moderate gene interaction	215	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Delay Results Group	Taking an antidepressant with moderate gene interaction	373	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Intervention Group	Taking an antidepressant with substantial gene interaction	79	Participants
Use of Fewer Medications That Have Potential Gene-drug Interactions	Delay Results Group	Taking an antidepressant with substantial gene interaction	133	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention Group	966
Overall Study	STARTED	Delay Results Group	978
Overall Study	COMPLETED	Intervention Group	754
Overall Study	COMPLETED	Delay Results Group	787
Overall Study	NOT COMPLETED	Intervention Group	212
Overall Study	NOT COMPLETED	Delay Results Group	191

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Intervention Group	345	966	676
other	Headache	Nervous system disorders	Delay Results Group	370	978	705
other	Sexual side effects	Reproductive system and breast disorders	Intervention Group	409	966	982
other	Sexual side effects	Reproductive system and breast disorders	Delay Results Group	402	978	1,026
other	GI distress	Gastrointestinal disorders	Intervention Group	272	966	461
other	GI distress	Gastrointestinal disorders	Delay Results Group	235	978	417
other	Nausea	Gastrointestinal disorders	Intervention Group	272	966	461
other	Nausea	Gastrointestinal disorders	Delay Results Group	235	978	417
other	Fatigue	Nervous system disorders	Intervention Group	130	966	185
other	Fatigue	Nervous system disorders	Delay Results Group	108	978	161

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention Group	2	966
Total, all-cause mortality	Delay Results Group	2	978
Total, other adverse events	Intervention Group	650	966
Total, other adverse events	Delay Results Group	636	978
Total, serious adverse events	Intervention Group	76	966
Total, serious adverse events	Delay Results Group	70	978

Source ClinicalTrials.gov

Papers55

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26458734	BACKGROUND	PubMed
28224735	BACKGROUND	PubMed
28512750	BACKGROUND	PubMed
28831200	BACKGROUND	PubMed
29074231	BACKGROUND	PubMed
29369448	BACKGROUND	PubMed
29457195	BACKGROUND	PubMed
29516993	BACKGROUND	PubMed
29536616	BACKGROUND	PubMed
29807071	BACKGROUND	PubMed

1 to 10 of 55

See all 55 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention Group vs Delay Results Group: Depression Response	Trial comparisons
Intervention Group vs Delay Results Group: Depression Remission	Trial comparisons
Intervention Group vs Delay Results Group: deaths from any cause	Trial comparisons
Intervention Group vs Delay Results Group: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03170362

GET https://conductscience.org/api/trials/v1/NCT03170362/events?page=2

API reference For AI assistants