Trial · NCT01814332
Analyzing Female Trauma Exposed Responses to a Medication
NCT01814332, Phase 2, Completed, VA Office of Research and Development; results first posted 2016-04-25
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Analyzing Female Trauma Exposed Responses to a Medication. Trials, record NCT01814332. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01814332
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Analyzing Female Trauma Exposed Responses to a Medication
- NCT number
- NCT01814332
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 128 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Stress Disorders, Post-traumatic
- Interventions
- GSK561679, Placebo
- First posted
- 2013-03-19
- Last updated
- 2021-06-25
- Results first posted
- 2016-04-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score | Baseline, 6 weeks | The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks. |
| Secondary | Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline | Baseline, Week 6 | The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured as having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms). |
| Secondary | Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline, Week 6 | The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks. |
| Secondary | Safety, Measured by the Number of Subjects That Experienced an Adverse Event | Baseline, Week 6 | The occurrence of adverse events will be recorded at the end of 6 weeks. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score | Baseline, 6 weeks | Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations. | score on a scale | MEAN |
| SECONDARY | Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline | Baseline, Week 6 | participants | NUMBER | |
| SECONDARY | Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline, Week 6 | Score on a scale | MEAN | |
| SECONDARY | Safety, Measured by the Number of Subjects That Experienced an Adverse Event | Baseline, Week 6 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score | GSK561679 | -26.02 | Standard Deviation 22.28 | score on a scale | |
| Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score | Placebo | -27.33 | Standard Deviation 19.76 | score on a scale | |
| Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline | GSK561679 | 14 | participants | ||
| Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline | Placebo | 18 | participants | ||
| Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | GSK561679 | -7.83 | Standard Deviation 9.32 | Score on a scale | |
| Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Placebo | -5.98 | Standard Deviation 9.10 | Score on a scale | |
| Safety, Measured by the Number of Subjects That Experienced an Adverse Event | GSK561679 | 55 | participants | ||
| Safety, Measured by the Number of Subjects That Experienced an Adverse Event | Placebo | 55 | participants |
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 | GSK561679 | 63 | |
| Overall Study | STARTED | Placebo | 65 | |
| Overall Study | COMPLETED | GSK561679 | 47 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | NOT COMPLETED | GSK561679 | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events72
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 | Tinnitus | Ear and labyrinth disorders | GSK561679 | 3 | 63 | 3 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 0 | 65 | 0 |
| other | Hot Flush | Endocrine disorders | GSK561679 | 0 | 63 | 0 |
| other | Hot Flush | Endocrine disorders | Placebo | 3 | 65 | 3 |
| other | Non-cardiac chest pain | Endocrine disorders | GSK561679 | 0 | 63 | 0 |
| other | Non-cardiac chest pain | Endocrine disorders | Placebo | 3 | 65 | 3 |
| other | Vision Blurred | Eye disorders | GSK561679 | 2 | 63 | 2 |
| other | Vision Blurred | Eye disorders | Placebo | 3 | 65 | 3 |
| other | Nausea | Gastrointestinal disorders | GSK561679 | 19 | 63 | 19 |
| other | Nausea | Gastrointestinal disorders | Placebo | 11 | 65 | 11 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK561679 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | GSK561679 | 55 | 63 |
| Total, other adverse events | Placebo | 55 | 65 |
| Total, serious adverse events | GSK561679 | 1 | 63 |
| Total, serious adverse events | Placebo | 1 | 65 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK561679 vs Placebo: Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline | Trial comparisons |
| GSK561679 vs Placebo: Safety, Measured by the Number of Subjects That Experienced an Adverse Event | Trial comparisons |
| GSK561679 vs Placebo: serious adverse events | 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.
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/NCT01814332
GET https://conductscience.org/api/trials/v1/NCT01814332/events?page=2