Trial · NCT05948540
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit). | 12 Weeks | A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome. |
| Primary | Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline. | 12 Weeks | The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). |
| Secondary | Frequency of treatment-emergent adverse events (TEAEs). | 12 Weeks | The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA. |
| Secondary | Severity of treatment-emergent adverse events (TEAEs). | 12 Weeks | The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA. |
| Secondary | Frequency of serious adverse events (SAEs) | 12 Weeks | The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA |
| Secondary | Severity of serious adverse events (SAEs). | 12 Weeks | The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA |
| Secondary | Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score. | 12 Weeks | A relative change in PTSD symptom severity from baseline as measured by the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome. |
| Secondary | Number of participants with a Response Rate ≥30% | 12 Weeks | ≥30% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome. |
| Secondary | Number of participants with a Response Rate ≥50% | 12 Weeks | ≥50% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome. |
| Secondary | Number of participants Achieving Remission. | 12 Weeks | Achieving remission: defined as the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score \<18. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. |
| Secondary | Relative and absolute change from Baseline in Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score at Weeks 4 and 8 | 8 Weeks | A relative change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome. |
| Secondary | Absolute change from Baseline at each post-Baseline Visit in questionnaires | Week 4, Week 6, Week 8, Week 12, and Week 16, when questionnaires are completed. | Generalized anxiety disorder screener (GAD-7) Timeline follow back (TLFB) for substance use Fagerström Test for Nicotine Dependence (FTND) Brief Inventory of Psychosocial Functioning (B-IPF) An abbreviated version of the World Health Organization Quality of Life (WHOQOL)-100 quality of life assessment (WHOQOL-BREF) Perceived Stress Scale (PSS) Brief Pain Inventory (BPI) Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) (mean average IDSIQ scores for 7-days prior to Weeks 4, 8, and 12) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05948540/registered