Trial · NCT07569198
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 | Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI) | From Baseline to Day 35 (Primary Endpoint) | The MSSI is a clinician administered scale used to assess presence or absence of suicidal ideation as well as intensity of suicidal ideation in the previous 48 hours. It consists of 18 items, with each item scored from 0 to 3. Total scores are summed and severity can be categorized as low (0-3), mild (9-20), or severe (\>21). |
| Secondary | Changes in suicidal ideation severity over a longer period of time using the Modified Scale for Suicidal Ideation (MSSI) | From Baseline to Month 6 and Month 9 | Evaluating changes in MSSI scores between baseline and Month 6 and between baseline and Month 9. The MSSI is a clinician administered scale used to assess presence or absence of suicidal ideation as well as intensity of suicidal ideation in the previous 48 hours. It consists of 18 items, with each item scored from 0 to 3. Total scores are summed and severity can be categorized as low (0-3), mild (9-20), or severe (\>21). |
| Secondary | Changes in suicidal behavior (SB) and self-harm (SH) using the Suicide Attempt Self-Injury Interview (SASII) | From Baseline to Months 3, 6, and 9 | The SASII is a semi-structured interview that will measure suicidal behavior and self-harm. The SASII is used to collect details of the topography, intent, medical severity, social context, precipitating and concurrent events, and outcomes of non-suicidal self-injury and suicidal behavior during a target time period (in this trial, the target time period will be 'past 3 months'). |
| Secondary | Changes in suicidal behavior (SB) and self-harm (SH) using the Lifetime Suicide Attempt Self-Injury Interview (L-SASII) | From Baseline to Months 3, 6, and 9 | The L-SASII will be administered at baseline to obtain a count of lifetime history of suicide attempts and non-suicidal self-injury. |
| Secondary | Changes in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | The MADRS is a clinician-rated scale measuring depression severity. It consists of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60. A higher score is indicative of greater depressive severity. |
| Secondary | Changes in personality psychopathology evaluated using the Borderline Symptom List-23 (BSL-23) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | Changes in borderline personality disorder symptom severity and general personality psychopathology will be evaluated using the BSL-23, self-report assessment. This scale assesses a list of 23 problems on a scale of 0-4. |
| Secondary | Changes in personality psychopathology using Level of Personality Functioning Scale (LPFS) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | Changes in borderline personality disorder symptom severity and general personality psychopathology will be assessed using the LPFS, an 80-item self-report assessment. Items are rated on a scale from 1 to 4, with 1 indicating "totally false, not true at all" and 4 indicating "very true". |
| Secondary | Changes in personality psychopathology using the Symptom-Checklist-90-Revised (SCL-90-R) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | Changes in borderline personality disorder symptom severity and general personality psychopathology will be assessed using the SCL-90-R, a 90-item self-report assessment. |
| Secondary | Changes in anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | The GAD-7 is a brief self-report measure of generalized anxiety. It consists of 7 items rated from 0 ('not at all sure') to 3 ('nearly every day'). |
| Secondary | Safety and tolerability evaluated by Adverse Events | Across 9 Months | Safety and tolerability will be evaluated by acute and sub-acute treatment-emergent adverse events using standardized adverse effects monitoring. |
| Secondary | Safety and tolerability measured by using the Clinician Administered Dissociative Symptom Scale (CADSS) | Across 9 months | Safety and tolerability will be evaluated using CADSS. It is a clinician administered instrument for the measurement of present-state dissociative symptoms. It is a 27-item scale with 19 subject-rated items and 8-items scored by an observer. |
| Secondary | Safety and tolerability evaluated by the Brief Psychiatric Rating Scale - Positive Symptom Subscale (BPRS-PS) | Across 9 months | The BPRS is a clinician-administered scale that measures positive symptoms, general psychopathology, and affective symptoms to measure psychopathology severity. The positive symptoms subscale will be administered, which measures symptoms commonly seen in psychosis, including unusual thought content, conceptual disorganization, hallucinatory behaviour, and grandiosity. |
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
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