Trial · NCT00302107
A Placebo-Controlled Study of Mirtazapine for PTSD
NCT00302107, Phase 4, Completed, US Department of Veterans Affairs; results first posted 2014-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Placebo-Controlled Study of Mirtazapine for PTSD. Trials, record NCT00302107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00302107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-Controlled Study of Mirtazapine for PTSD
- NCT number
- NCT00302107
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 78 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Anxiety, PTSD
- Interventions
- Mirtazapine, Placebo
- First posted
- 2006-03-13
- Last updated
- 2014-11-26
- Results first posted
- 2014-11-26
- Limitations and caveats
- Small sample of predominantly male combat veterans limits generalizability of findings.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Structured Interview of Posttraumatic Stress Disorder (SIP) | Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score. | Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Structured Interview of Posttraumatic Stress Disorder (SIP) | Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score. | Randomized, took at least one dose of study medication, and returned for at least one visit post-randomization | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Structured Interview of Posttraumatic Stress Disorder (SIP) | Mirtazapine | -7.61 | Standard Deviation 9.89 | units on a scale | |
| Structured Interview of Posttraumatic Stress Disorder (SIP) | Placebo | -5.83 | Standard Deviation 7.41 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirtazapine | 39 | |
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | COMPLETED | Mirtazapine | 31 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | Mirtazapine | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events2
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 | Any Adverse Event | General disorders | Mirtazapine | 22 | 39 | 22 |
| other | Any Adverse Event | General disorders | Placebo | 24 | 39 | 24 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirtazapine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mirtazapine | 22 | 39 |
| Total, other adverse events | Placebo | 24 | 39 |
| Total, serious adverse events | Mirtazapine | 0 | 39 |
| Total, serious adverse events | Placebo | 0 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33084254 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mirtazapine vs Placebo: serious adverse events |
Source 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.
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/NCT00302107
GET https://conductscience.org/api/trials/v1/NCT00302107/registered