Trial · NCT06967857
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 62
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6 | from enrollment to the end of study at week 17 | Incidence of adverse events (AE) in the active treatment groups (DEX XL and DEX IR) compared to the placebo until V6 |
| Secondary | Incidence of adverse events (AE) until V5 | Start with enrollment until end of treatment at Week 16 | Dokumentation of AE |
| Secondary | Proportion of patients with at least one AE until V5 | through study treatment (up to 16 weeks) | Proportion of patients with at least one AE until V5 |
| Secondary | Proportion of patients with at least one AE until end of study | from baseline until end of study at week 17 | Proportion of patients with at least one AE until end of study |
| Secondary | Number of AE until V5 | through study treatment (up to 16 weeks) | Number of AE |
| Secondary | Number of AE until V5 and until end of study | from baseline until end of study at week 17 | Number of AE |
| Secondary | Number of AE/SAE during the study period | through study treatment (up to 16 weeks) | Number of AE/SAE |
| Secondary | number of patients with AE/SAE by type during study period | through study treatment (up to 16 weeks) | Number and type of AE/SAE |
| Secondary | proportion of patients with AE/SAE by type during study period | through study treatment (up to 16 weeks) | Proportion of patient with AE/SAE by type |
| Secondary | number of patients with AE/SAE by severity (mild, moderate, severe) during study period | through study treatment (up to 16 weeks) | number of patients with AE/SAE by severity (mild, moderate, severe) |
| Secondary | proportion of patients with AE/SAE by severity (mild, moderate, severe) during study period | through study treatment (up to 16 weeks) | proportion of patients with AE/SAE by severity (mild, moderate, severe) |
| Secondary | number of patients with AE/SAE by relatedness to treatment during study period | through study treatment (up to 16 weeks) | number of patients with AE/SAE by relatedness to treament |
| Secondary | proportion of patients with AE/SAE by relatedness to treatment during study period | from enrollment to the end of study at week 17 | proportion of patients with AE/SAE by relatedness to treatment |
| Secondary | Score of clinical global impression (CGI) Efficacy index by investigator at Visit 5 | 16 weeks after treatment start | Clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in patients with mental disorders. It is a brief 3-item observer-rated scale. 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects. Treatment is evaluated from "marked improvement" to "none/worsening". Side effects is evaluated from "none" to "outweigh therapeutic effect" |
| Secondary | MADRS suicidal ideation score for all available visits (screening to Visit 5) | from enrollment to the end of treatment (up to week 16) | Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
| Secondary | MADRS suicidal ideation score for all available visits | from enrollment to end of titration at week 4 (V1) | Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
| Secondary | MADRS suicidal ideation score for all available visits | from enrollment to week 7 (V2) | Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
| Secondary | MADRS suicidal ideation score change to BL/V0 (on V1) | from baseline to end of treatment titration phase at 4 weeks | Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
| Secondary | MADRS suicidal ideation score change to BL/V0 (on V5) | from treatment start to end of treatment at 16 weeks | Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
| Secondary | MADRS suicidal ideation score for all available visits | from enrollment to 10 weeks (V3) | Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
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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