Trial · NCT00292370
Quetiapine Augmentation for Treatment-resistant PTSD
NCT00292370, Phase 4, Completed, VA Office of Research and Development; results first posted 2014-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Quetiapine Augmentation for Treatment-resistant PTSD. Trials, record NCT00292370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00292370
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quetiapine Augmentation for Treatment-resistant PTSD
- NCT number
- NCT00292370
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 124 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Combat Disorders, Stress Disorders, Post-Traumatic
- Interventions
- Open Label (OL) Paroxetine, Placebo, Quetiapine
- First posted
- 2006-02-15
- Last updated
- 2019-10-16
- Results first posted
- 2014-07-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | From baseline (week 8) to endpoint (week 16 or termination) | The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change. |
| Secondary | Change in CGI-I | From Baseline (week 8) to Endpoint (week 16 or termination) | Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. |
| Secondary | Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Baseline (week 8) to Endpoint (week 16 or termination) | Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms. |
| Secondary | Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | From Baseline (week 8) to Endpoint (week 16 or Termination) | Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale. |
| Secondary | Change in Total Mean Davidson Trauma Scale (DTS) | From Baseline (week 8) to Endpoint (week 16 or Termination) | The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D). |
| Secondary | Change in Mean Q-LES-Q Score From Baseline to Endpoint. | From Baseline (week 8) to Endpoint (week 16 or termination) | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life. |
| Secondary | Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | From Baseline (week 8) to Endpoint (week 16) | The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality. |
| Secondary | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline (week 8) to Endpoint (week 16 or termination) | The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe). |
| Secondary | Change in Arizona Sexual Experience Scale (ASEX) | From Baseline (week 8) to Endpoint (week 16 or termination) | The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | From baseline (week 8) to endpoint (week 16 or termination) | units on a scale | MEAN | |
| SECONDARY | Change in CGI-I | From Baseline (week 8) to Endpoint (week 16 or termination) | Randomized participants with CGI-I score | units on a scale | MEAN |
| SECONDARY | Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Baseline (week 8) to Endpoint (week 16 or termination) | Randomized participants with a PANSS score | units on a scale | MEAN |
| SECONDARY | Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | From Baseline (week 8) to Endpoint (week 16 or Termination) | Randomized participants with a HAMD score. | units on a scale | MEAN |
| SECONDARY | Change in Total Mean Davidson Trauma Scale (DTS) | From Baseline (week 8) to Endpoint (week 16 or Termination) | Randomized participants with a DTS score | units on a scale | MEAN |
| SECONDARY | Change in Mean Q-LES-Q Score From Baseline to Endpoint. | From Baseline (week 8) to Endpoint (week 16 or termination) | Randomized participants with a Q-LES-Q score. | units on a scale | MEAN |
| SECONDARY | Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | From Baseline (week 8) to Endpoint (week 16) | Randomized participants with a PSQI score. | units on a scale | MEAN |
| SECONDARY | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline (week 8) to Endpoint (week 16 or termination) | Randomized participants with an SDS score | units on a scale | MEAN |
| SECONDARY | Change in Arizona Sexual Experience Scale (ASEX) | From Baseline (week 8) to Endpoint (week 16 or termination) | Randomized participants with an ASEX score. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | Arm 2 OL Paroxetine + DB Placebo | CAPS Total Baseline | 72.15 | Standard Deviation 15.96 | units on a scale |
| Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | Arm 3: OL Paroxetine + DB Quetiapine | CAPS Total Baseline | 68.78 | Standard Deviation 17.01 | units on a scale |
| Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | Arm 2 OL Paroxetine + DB Placebo | CAPS Total Endpoint | 67.90 | Standard Deviation 14.90 | units on a scale |
| Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | Arm 3: OL Paroxetine + DB Quetiapine | CAPS Total Endpoint | 51.52 | Standard Deviation 19.68 | units on a scale |
| Change in CGI-I | Arm 2 OL Paroxetine + DB Placebo | Baseline CGI-I | 3.56 | Standard Deviation .85 | units on a scale |
| Change in CGI-I | Arm 3: OL Paroxetine + DB Quetiapine | Baseline CGI-I | 3.36 | Standard Deviation .88 | units on a scale |
| Change in CGI-I | Arm 2 OL Paroxetine + DB Placebo | Endpoint CGI-I | 2.61 | Standard Deviation .79 | units on a scale |
| Change in CGI-I | Arm 3: OL Paroxetine + DB Quetiapine | Endpoint CGI-I | 2.22 | Standard Deviation 1.19 | units on a scale |
| Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Arm 2 OL Paroxetine + DB Placebo | Baseline Total PANSS | 46.63 | Standard Deviation 10.13 | units on a scale |
| Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Arm 3: OL Paroxetine + DB Quetiapine | Baseline Total PANSS | 47.76 | Standard Deviation 11.09 | units on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I - Open-Label Paroxetine (OLP) | STARTED | Arm 1/Open-Label (OL) Paroxetine | 124 | |
| Phase I - Open-Label Paroxetine (OLP) | STARTED | Arm 2/OL Paroxetine & Double-blind Placebo | 0 | |
| Phase I - Open-Label Paroxetine (OLP) | STARTED | Arm 3/OL Paroxetine & Double-blind Quetiapine | 0 | |
| Phase I - Open-Label Paroxetine (OLP) | COMPLETED | Arm 1/Open-Label (OL) Paroxetine | 78 | |
| Phase I - Open-Label Paroxetine (OLP) | COMPLETED | Arm 2/OL Paroxetine & Double-blind Placebo | 0 | |
| Phase I - Open-Label Paroxetine (OLP) | COMPLETED | Arm 3/OL Paroxetine & Double-blind Quetiapine | 0 | |
| Phase I - Open-Label Paroxetine (OLP) | NOT COMPLETED | Arm 1/Open-Label (OL) Paroxetine | 46 | |
| Phase I - Open-Label Paroxetine (OLP) | NOT COMPLETED | Arm 2/OL Paroxetine & Double-blind Placebo | 0 | |
| Phase I - Open-Label Paroxetine (OLP) | NOT COMPLETED | Arm 3/OL Paroxetine & Double-blind Quetiapine | 0 | |
| Phase II: OLP + DB Quetiapine or Placebo | STARTED | Arm 1/Open-Label (OL) Paroxetine | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events27
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 | Sexual Side effects | Reproductive system and breast disorders | Arm 1: Open Label (OL) Paroxetine | 10 | 124 | 10 |
| other | Sexual Side effects | Reproductive system and breast disorders | Arm 2 OL Paroxetine + DB Placebo | 1 | 25 | 1 |
| other | Sexual Side effects | Reproductive system and breast disorders | Arm 3: OL Paroxetine + DB Quetiapine | 1 | 25 | 1 |
| other | Sedation | Nervous system disorders | Arm 1: Open Label (OL) Paroxetine | 7 | 124 | 7 |
| other | Sedation | Nervous system disorders | Arm 2 OL Paroxetine + DB Placebo | 1 | 25 | 1 |
| other | Sedation | Nervous system disorders | Arm 3: OL Paroxetine + DB Quetiapine | 3 | 25 | 3 |
| other | Dizziness | Nervous system disorders | Arm 1: Open Label (OL) Paroxetine | 6 | 124 | 6 |
| other | Dizziness | Nervous system disorders | Arm 2 OL Paroxetine + DB Placebo | 0 | 25 | 0 |
| other | Dizziness | Nervous system disorders | Arm 3: OL Paroxetine + DB Quetiapine | 0 | 25 | 0 |
| other | Heart palpitation | Cardiac disorders | Arm 1: Open Label (OL) Paroxetine | 0 | 124 | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Open Label (OL) Paroxetine | ||
| Total, all-cause mortality | Arm 2 OL Paroxetine + DB Placebo | ||
| Total, all-cause mortality | Arm 3: OL Paroxetine + DB Quetiapine | ||
| Total, other adverse events | Arm 1: Open Label (OL) Paroxetine | 23 | 124 |
| Total, other adverse events | Arm 2 OL Paroxetine + DB Placebo | 2 | 25 |
| Total, other adverse events | Arm 3: OL Paroxetine + DB Quetiapine | 8 | 25 |
| Total, serious adverse events | Arm 1: Open Label (OL) Paroxetine | 5 | 124 |
| Total, serious adverse events | Arm 2 OL Paroxetine + DB Placebo | 0 | 25 |
| Total, serious adverse events | Arm 3: OL Paroxetine + DB Quetiapine | 2 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 11387733 | BACKGROUND |
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.
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.
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