Trial · NCT07888933
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Psychiatric Hospital Discharge | From the first study infusion until discharge from the index psychiatric hospitalization, assessed up to 6 months. | Time, in days, from the first study infusion to discharge from the index psychiatric hospitalization. Hospital discharge will be considered the event of interest. Participants who do not experience the event during the observation period will be censored at the last date for which outcome information is available. Time to discharge will be compared between participants randomized to intravenous esketamine and participants randomized to active placebo. |
| Secondary | Remission of Suicidal Ideation at 72 Hours | 72 hours after the first study infusion | Proportion of participants achieving complete remission of suicidal ideation, defined as a Scale for Suicide Ideation (SSI) score ≤3. |
| Secondary | Change in Suicidal Ideation Severity | Baseline through Week 12 | Change in clinician-rated and self-rated Scale for Suicide Ideation (SSI) scores from baseline across treatment and follow-up assessments. Higher scores indicate greater severity of suicidal ideation. |
| Secondary | Suicidal Ideation and Behavior During Follow-up | Baseline through Week 12 | Change in suicidal ideation and occurrence of suicidal behavior assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). |
| Secondary | Suicide Attempts During Follow-up | From the first study infusion through Week 12 | Number and proportion of participants experiencing at least one suicide attempt during clinical follow-up. |
| Secondary | Change in Depressive Symptoms Assessed by PHQ-9 | Baseline through Week 12 | Change in Patient Health Questionnaire-9 total score from baseline. Higher scores indicate greater severity of depressive symptoms. |
| Secondary | Change in Depressive Symptoms Assessed by QIDS-SR | Baseline through Week 12 | Change in Quick Inventory of Depressive Symptomatology-Self-Report total score from baseline. |
| Secondary | Change in Clinician-Rated Depressive Symptoms | Baseline through Week 12 | Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) total score from baseline. |
| Secondary | Change in Psychological Pain | Baseline through Week 12 | Change in Psychological Pain Visual Analog Scale (PPP-VAS) score from baseline. |
| Secondary | Change in Hopelessness | Baseline through Week 12 | Change in Beck Hopelessness Scale (BHS) total score from baseline. Higher scores indicate greater hopelessness. |
| Secondary | Clinical Global Improvement | Through Week 12 | Overall clinical improvement assessed using the Clinical Global Impression-Improvement (CGI-I) scale. |
| Secondary | Change in Manic Symptoms | Baseline through Week 12 | Change in Young Mania Rating Scale (YMRS) total score during treatment and follow-up. |
| Secondary | Change in General Psychiatric Symptoms | Baseline through Week 12 | Change in Brief Psychiatric Rating Scale (BPRS) total score during treatment and follow-up. |
| Secondary | Dissociative Symptoms | After the first study infusion and at weeks 1, 2, 4, 6 and 12. | Severity of dissociative symptoms assessed using the Clinician-Administered Dissociative States Scale (CADSS) after the first study infusion and at weeks 1, 2, 4, 6 and 12. |
| Secondary | Treatment-Emergent Adverse Events | From the first study infusion through Week 12 | Incidence and severity of adverse events occurring during study treatment and clinical follow-up. |
| Secondary | Treatment-Related Healthcare Costs | From the first study infusion through Week 12 | Healthcare costs associated with the index psychiatric hospitalization, medications, and psychotherapeutic treatments. |
| Other | Change in Plasma Brain-Derived Neurotrophic Factor (BDNF) Levels | Baseline, 24-72 hours after the first infusion, Week 2, and Week 6. | Change from baseline in plasma brain-derived neurotrophic factor (BDNF) concentrarion, measured using a luminex-based multiplex assay and expressed in ng/ml. |
| Other | Change in Plasma Interleukin-6 (IL-6) Concentration | Baseline, 24-72 hours after the first study infusion, Week 2, and Week 6. | Change from baseline in plasma interleukin-6 (IL-6) concentration, measured using a Luminex-based multiplex assay and expressed in pg/mL. |
| Other | Change in Plasma Tumor Necrosis Factor-Alpha (TNF-α) Concentration | Baseline, 24-72 hours after the first study infusion, Week 2, and Week 6. | Change from baseline in plasma tumor necrosis factor-alpha (TNF-α) concentration, measured using a Luminex-based multiplex assay and expressed in pg/mL. |
| Other | Change in Plasma Interleukin-1 Beta (IL-1β) Concentration | Baseline, 24-72 hours after the first study infusion, Week 2, and Week 6. | Change from baseline in plasma interleukin-1 beta (IL-1β) concentration, measured using a Luminex-based multiplex assay and expressed in pg/mL. |
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.
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