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Trial · NCT04597190

Sequenced Treatment Effectiveness for Posttraumatic Stress

NCT04597190, Phase 4, Completed, University of Washington; results first posted 2025-03-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Sequenced Treatment Effectiveness for Posttraumatic Stress. Trials, record NCT04597190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04597190

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Trial

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

Title
Sequenced Treatment Effectiveness for Posttraumatic Stress
NCT number
NCT04597190
Status
Completed
Phases
Phase 4
Enrollment
700 participants, actual
Lead sponsor
University of Washington
Conditions
PTSD
Interventions
Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor, Written Exposure Therapy
First posted
2020-10-22
Last updated
2025-05-08
Results first posted
2025-03-26

Source ClinicalTrials.gov

Registered outcomes10

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

ListOutcomeTime frameDescription
PrimaryPTSD Symptoms4 months (Hypothesis 1)Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
PrimaryPTSD Symptoms8 Months (Hypotheses 2a and 2b)Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
SecondaryMental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score4 months (Hypothesis 1)SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
SecondaryMental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score8 Months (Hypotheses 2a and 2b)SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
SecondaryDepression Symptoms4 months (Hypothesis 1)Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
SecondaryDepression Symptoms8 Months (Hypotheses 2a and 2b)Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
SecondaryGeneralized Anxiety Symptoms4 months (Hypothesis 1)Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
SecondaryGeneralized Anxiety Symptoms8 Months (Hypotheses 2a and 2b)Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
OtherNumber of Severe and Moderate Side Effects4 months (Hypothesis 1)Self reported severity of specific side-effects
OtherNumber of Severe and Moderate Side Effects8 Months (Hypotheses 2a and 2b)Self reported severity of specific side-effects

Outcomes10

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPTSD Symptoms4 months (Hypothesis 1)units on a scaleMEAN
PRIMARYPTSD Symptoms8 Months (Hypotheses 2a and 2b)Participants not responding to treatment at 4-months who completed the 8-month surveyunits on a scaleMEAN
SECONDARYMental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score4 months (Hypothesis 1)units on a scaleMEAN
SECONDARYMental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score8 Months (Hypotheses 2a and 2b)Participants not responding to treatment at 4-months who completed the 8-month surveyunits on a scaleMEAN
SECONDARYDepression Symptoms4 months (Hypothesis 1)Participants completing the 4-month surveyunits on a scaleMEAN
SECONDARYDepression Symptoms8 Months (Hypotheses 2a and 2b)Participants not responding to treatment at 4-months who completed the 8-month surveyunits on a scaleMEAN
SECONDARYGeneralized Anxiety Symptoms4 months (Hypothesis 1)Participants completing the survey at 4-monthsunits on a scaleMEAN
SECONDARYGeneralized Anxiety Symptoms8 Months (Hypotheses 2a and 2b)Participants not responding to treatment at 4-months who completed the 8-month surveyunits on a scaleMEAN
OTHER_PRE_SPECIFIEDNumber of Severe and Moderate Side Effects4 months (Hypothesis 1)Participants completing the 4-month surveyNumber of side-effectsMEAN
OTHER_PRE_SPECIFIEDNumber of Severe and Moderate Side Effects8 Months (Hypotheses 2a and 2b)Participants not responding to treatment at 4-months who completed the 8-month surveyNumber of side-effectsMEAN

Results by group30

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

OutcomeGroupCategoryValueSpreadUnits
PTSD SymptomsSSRI Then Augmentation by WET39.3Standard Deviation 17.8units on a scale
PTSD SymptomsSSRI Then Switch to SNRI38.6Standard Deviation 17.0units on a scale
PTSD SymptomsWET Then Switch to SSRI40.5Standard Deviation 18.4units on a scale
PTSD SymptomsSSRI Then Augmentation by WET49.3Standard Deviation 17.0units on a scale
PTSD SymptomsSSRI Then Switch to SNRI42.1Standard Deviation 17.2units on a scale
PTSD SymptomsWET Then Switch to SSRI44.5Standard Deviation 17.3units on a scale
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary ScoreSSRI Then Augmentation by WET34.7Standard Deviation 11.6units on a scale
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary ScoreSSRI Then Switch to SNRI34.1Standard Deviation 12.2units on a scale
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary ScoreWET Then Switch to SSRI32.9Standard Deviation 11.0units on a scale
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary ScoreSSRI Then Augmentation by WET29.4Standard Deviation 12.3units on a scale

Participant flow9

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDSSRI Then Augmentation by WET169
Overall StudySTARTEDSSRI Then Switch to SNRI179
Overall StudySTARTEDWET Then Switch to SSRI352
Overall StudyCOMPLETEDSSRI Then Augmentation by WET145
Overall StudyCOMPLETEDSSRI Then Switch to SNRI150
Overall StudyCOMPLETEDWET Then Switch to SSRI295
Overall StudyNOT COMPLETEDSSRI Then Augmentation by WET24
Overall StudyNOT COMPLETEDSSRI Then Switch to SNRI29
Overall StudyNOT COMPLETEDWET Then Switch to SSRI57

Adverse events18

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherIncrease in suicide ideationInvestigationsSSRI Then Augmentation by WET3316933
otherIncrease in suicide ideationInvestigationsSSRI Then Switch to SNRI3517935
otherIncrease in suicide ideationInvestigationsWET Then Switch to SSRI6035260
otherNon-suicidal injuryInvestigationsSSRI Then Augmentation by WET11691
otherNon-suicidal injuryInvestigationsSSRI Then Switch to SNRI01790
otherNon-suicidal injuryInvestigationsWET Then Switch to SSRI03520
seriousHospitalizationInvestigationsSSRI Then Augmentation by WET11691
seriousHospitalizationInvestigationsSSRI Then Switch to SNRI31793
seriousHospitalizationInvestigationsWET Then Switch to SSRI73527
seriousEmergency Department AdmissionInvestigationsSSRI Then Augmentation by WET01690

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalitySSRI Then Augmentation by WET0169
Total, all-cause mortalitySSRI Then Switch to SNRI0179
Total, all-cause mortalityWET Then Switch to SSRI1352
Total, other adverse eventsSSRI Then Augmentation by WET34169
Total, other adverse eventsSSRI Then Switch to SNRI35179
Total, other adverse eventsWET Then Switch to SSRI60352
Total, serious adverse eventsSSRI Then Augmentation by WET32169
Total, serious adverse eventsSSRI Then Switch to SNRI34179
Total, serious adverse eventsWET Then Switch to SSRI63352

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
41091477DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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/NCT04597190

GET https://conductscience.org/api/trials/v1/NCT04597190/results?page=2