Trial · NCT03765138
Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
NCT03765138, Phase 3, Terminated, Research Foundation for Mental Hygiene, Inc.; results first posted 2019-11-26
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression. Trials, record NCT03765138. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03765138
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
- NCT number
- NCT03765138
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Conditions
- PTSD, MDD
- Interventions
- PE/Pramipexole
- First posted
- 2018-12-05
- Last updated
- 2019-11-26
- Results first posted
- 2019-11-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in PTSD Symptoms as Measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline, Week 5, Week 10, 3 month follow up | The CAPS is the gold standard in PTSD assessment. It is a 30-item structured interview used for current (past week or month) and lifetime diagnosis of PTSD. The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD. The full interview takes 45-60 minutes to administer. Scores range from 0 to 80 with higher values represent a worse outcome. |
| Primary | Change in Depressive Symptoms as Measured by the Hamilton Rating Scale for Depression (HRSD). | Baseline, Week 5, Week 10, 3 month follow up | The Hamilton Rating Scale for Depression is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from 0 to 61, with higher values represent a worse outcome. |
| Secondary | Changes in Functional Connectivity of Fear and Reward Pathways as Measured by Functional Magentic Resonance Imaging (fMRI) Resting State Functional Connectivity (Rs-FC). | baseline and week 10. | The investigators will use fMRI scans at baseline and posttreatment to assess connectivity in fear and reward circuits |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in PTSD Symptoms as Measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline, Week 5, Week 10, 3 month follow up | Participant did not complete protocol. | ||
| PRIMARY | Change in Depressive Symptoms as Measured by the Hamilton Rating Scale for Depression (HRSD). | Baseline, Week 5, Week 10, 3 month follow up | Study discontinued | ||
| SECONDARY | Changes in Functional Connectivity of Fear and Reward Pathways as Measured by Functional Magentic Resonance Imaging (fMRI) Resting State Functional Connectivity (Rs-FC). | baseline and week 10. | Study discontinued |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PE/Pramipexole | 1 | |
| Overall Study | COMPLETED | PE/Pramipexole | 0 | |
| Overall Study | NOT COMPLETED | PE/Pramipexole | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PE/Pramipexole | 0 | 1 |
| Total, other adverse events | PE/Pramipexole | 0 | 1 |
| Total, serious adverse events | PE/Pramipexole | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03765138
GET https://conductscience.org/api/trials/v1/NCT03765138/registered