Trial · NCT03466346
SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project
NCT03466346, Not applicable, Completed, University of California, San Francisco; results first posted 2025-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project. Trials, record NCT03466346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03466346
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project
- NCT number
- NCT03466346
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,162 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Depression, Unipolar, Posttraumatic Stress Disorder, Trauma
- Interventions
- Fluoxetine, Interpersonal Psychotherapy
- First posted
- 2018-03-15
- Last updated
- 2025-12-02
- Results first posted
- 2025-12-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Major Depression at End of Treatment | End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12) | Number of Participants with Major Depression. The Beck Depression Inventory-Second Edition (BDI-II) was used and a score of 19 or greater was defined as positive for major depression. BDI-II score below 19 is defined as negative for major depression. Scores range from 0 to 63 with higher total scores indicating more severe depressive symptoms. |
| Primary | Number of Participants With PTSD | End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12) | Number of Participants with PTSD. The PTSD Checklist for DSM-5 (PCL-5) was used and score of 23 or greater is defined as positive for PTSD. PCL-5 score below 23 is defined as negative for PTSD. Score range from 0 to 80 with higher total scores indicating more severe PTSD symptoms. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Major Depression at End of Treatment | End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12) | Number of participants with Major Depression in each arm at the end of 1st line Treatment (Stage 1) and the end of 2nd line Treatment (Stage 2) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PTSD | End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12) | Number of participants with PTSD in each arm at end of 1st line Treatment (Stage 1) and end of 2nd line Treatment (Stage 2) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Major Depression at End of Treatment | Stage 1: Interpersonal Psychotherapy (IPT) | 127 | Participants | ||
| Number of Participants With Major Depression at End of Treatment | Stage 1: Fluoxetine | 89 | Participants | ||
| Number of Participants With Major Depression at End of Treatment | Stage 2: Fluoxetine After IPT | 6 | Participants | ||
| Number of Participants With Major Depression at End of Treatment | Stage 2: IPT After Fluoxetine | 11 | Participants | ||
| Number of Participants With Major Depression at End of Treatment | Stage 2: Fluoxetine and IPT | 11 | Participants | ||
| Number of Participants With PTSD | Stage 1: Interpersonal Psychotherapy (IPT) | 173 | Participants | ||
| Number of Participants With PTSD | Stage 1: Fluoxetine | 108 | Participants | ||
| Number of Participants With PTSD | Stage 2: Fluoxetine After IPT | 10 | Participants | ||
| Number of Participants With PTSD | Stage 2: IPT After Fluoxetine | 14 | Participants | ||
| Number of Participants With PTSD | Stage 2: Fluoxetine and IPT | 20 | Participants |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1 - 1st Line Trt (IPT or FLX) | STARTED | Stage 1: Interpersonal Psychotherapy | 1,082 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | STARTED | Stage 1: Fluoxetine | 1,080 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | STARTED | Stage 2: IPT After Fluoxetine | 0 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | STARTED | Stage 2: Fluoxetine After IPT | 0 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | STARTED | Stage 2: IPT and Fluoxetine | 0 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | COMPLETED | Stage 1: Interpersonal Psychotherapy | 986 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | COMPLETED | Stage 1: Fluoxetine | 878 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | COMPLETED | Stage 2: IPT After Fluoxetine | 0 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | COMPLETED | Stage 2: Fluoxetine After IPT | 0 | |
| Stage 1 - 1st Line Trt (IPT or FLX) | COMPLETED | Stage 2: IPT and Fluoxetine | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events285
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 | Abdominal Pain | Gastrointestinal disorders | Stage 1: Interpersonal Psychotherapy (IPT) | 12 | 1,082 | |
| other | Abdominal Pain | Gastrointestinal disorders | Stage 1: Fluoxetine | 2 | 1,080 | |
| other | Abdominal Pain | Gastrointestinal disorders | Stage 2: IPT After Fluoxetine | 0 | 68 | |
| other | Abdominal Pain | Gastrointestinal disorders | Stage 2: Fluoxetine After IPT | 0 | 104 | |
| other | Abdominal Pain | Gastrointestinal disorders | Stage 2: Fluoxetine and IPT | 2 | 160 | |
| other | Abnormal Laboratory Results | Investigations | Stage 1: Interpersonal Psychotherapy (IPT) | 1 | 1,082 | |
| other | Abnormal Laboratory Results | Investigations | Stage 1: Fluoxetine | 1 | 1,080 | |
| other | Abnormal Laboratory Results | Investigations | Stage 2: IPT After Fluoxetine | 0 | 68 | |
| other | Abnormal Laboratory Results | Investigations | Stage 2: Fluoxetine After IPT | 0 | 104 | |
| other | Abnormal Laboratory Results | Investigations | Stage 2: Fluoxetine and IPT | 0 | 160 |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: Interpersonal Psychotherapy (IPT) | 7 | 1,082 |
| Total, all-cause mortality | Stage 1: Fluoxetine | 14 | 1,080 |
| Total, all-cause mortality | Stage 2: IPT After Fluoxetine | 1 | 68 |
| Total, all-cause mortality | Stage 2: Fluoxetine After IPT | 1 | 104 |
| Total, all-cause mortality | Stage 2: Fluoxetine and IPT | 0 | 160 |
| Total, other adverse events | Stage 1: Interpersonal Psychotherapy (IPT) | 326 | 1,082 |
| Total, other adverse events | Stage 1: Fluoxetine | 139 | 1,080 |
| Total, other adverse events | Stage 2: IPT After Fluoxetine | 5 | 68 |
| Total, other adverse events | Stage 2: Fluoxetine After IPT | 10 | 104 |
| Total, other adverse events | Stage 2: Fluoxetine and IPT | 16 | 160 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01MH113722 | Effectiveness Research for Common Mental Disorders in Low and Middle Income Countries: A sequential, multiple assignment randomized trial for non-specialist treatment strategies in Kenya | MEFFERT, SUSAN M. | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE OF MENTAL HEALTH | 2019 to 2023 | NIH RePORTER |
| R01MH115512 | Depression And Primary-care Partnership for Effectiveness-implementation Research (DAPPER) | MATHAI, MUTHONI MUTHONI; MEFFERT, SUSAN M. | UNIVERSITY OF NAIROBI | NATIONAL INSTITUTE OF MENTAL HEALTH | 2018 to 2022 | NIH RePORTER |
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.
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/NCT03466346
GET https://conductscience.org/api/trials/v1/NCT03466346/flow?page=2