Trial · NCT00202449
Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance
NCT00202449, Not applicable, Terminated, Seattle Institute for Biomedical and Clinical Research; results first posted 2012-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance. Trials, record NCT00202449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00202449
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance
- NCT number
- NCT00202449
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 59 participants, actual
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Conditions
- Stress Disorders, Post-Traumatic, Sleep Disorders
- Interventions
- prazosin, paroxetine, Placebo
- First posted
- 2005-09-20
- Last updated
- 2018-07-10
- Results first posted
- 2012-07-12
- Limitations and caveats
- High rate of early termination leading to small number of patients analyzed.
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 Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12 | Baseline and Week 12 | Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12. Minimum = 0 Maximum = 8 |
| Primary | Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12 | Baseline to Week 12 | Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 12. |
| Primary | Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12 | Baseline to Week 12 | The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from baseline to Week 12. |
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 Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12 | Baseline and Week 12 | Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study). | scale points | MEAN |
| PRIMARY | Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12 | Baseline to Week 12 | Number of subjects analyzed equals the number of subjects who were able to complete this assessment at Week 12 (e.g., completed the study). | scale points | MEAN |
| PRIMARY | Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12 | Baseline to Week 12 | Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study). | scale points | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12 | Prazosin | -1.29 | Standard Deviation 1.11 | scale points | |
| Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12 | Paroxetine | -3.11 | Standard Deviation 2.52 | scale points | |
| Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12 | Placebo | -2.67 | Standard Deviation 3.0 | scale points | |
| Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12 | Prazosin | -2.33 | Standard Deviation 2.94 | scale points | |
| Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12 | Paroxetine | -6.44 | Standard Deviation 3.91 | scale points | |
| Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12 | Placebo | -3.33 | Standard Deviation 5.45 | scale points | |
| Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12 | Prazosin | 3.14 | Standard Deviation 1.86 | scale points | |
| Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12 | Paroxetine | 2.11 | Standard Deviation 1.05 | scale points | |
| Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12 | Placebo | 2.33 | Standard Deviation 1.22 | scale points |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prazosin | 18 | |
| Overall Study | STARTED | Paroxetine | 20 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | COMPLETED | Prazosin | 7 | |
| Overall Study | COMPLETED | Paroxetine | 9 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Prazosin | 11 | |
| Overall Study | NOT COMPLETED | Paroxetine | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events63
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 | nasal congestion | Respiratory, thoracic and mediastinal disorders | Prazosin | 0 | 18 | 0 |
| other | nasal congestion | Respiratory, thoracic and mediastinal disorders | Paroxetine | 0 | 20 | 0 |
| other | nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 21 | 1 |
| other | dry mouth | General disorders | Prazosin | 0 | 18 | 0 |
| other | dry mouth | General disorders | Paroxetine | 0 | 20 | 0 |
| other | dry mouth | General disorders | Placebo | 1 | 21 | 1 |
| other | dizziness | Ear and labyrinth disorders | Prazosin | 0 | 18 | 0 |
| other | dizziness | Ear and labyrinth disorders | Paroxetine | 0 | 20 | 0 |
| other | dizziness | Ear and labyrinth disorders | Placebo | 1 | 21 | 1 |
| other | stomach pain | Gastrointestinal disorders | Prazosin | 0 | 18 | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prazosin | ||
| Total, all-cause mortality | Paroxetine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Prazosin | 3 | 18 |
| Total, other adverse events | Paroxetine | 3 | 20 |
| Total, other adverse events | Placebo | 1 | 21 |
| Total, serious adverse events | Prazosin | 0 | 18 |
| Total, serious adverse events | Paroxetine | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 21 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00202449
GET https://conductscience.org/api/trials/v1/NCT00202449/events?page=2