Trial · NCT05913947
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hamilton Depressions scale, version 6 (HDS-6) | 8 weeks | The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome). |
| Secondary | Difference-in-difference for HDS-17 | Week 4 and 8 | Difference-in-differences for secondary continuous measures: Hamilton Depression Scale, 17 item version, HDS-17. (Values 0- 52, higher scores mean a worse outcome) |
| Secondary | Difference-in-differences in HDS-6 for the PP 8 population | 8 weeks | Difference-in-differences (baseline to 8 weeks) in HDS-6 for the PP 8 population. Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome). |
| Secondary | Between-groups difference in proportion of responders and remitters in HDS-6 Scores. | Week 4 and week 8 | Between-groups difference in proportion of responders and remitters at week 4 and 8 in HDS-6 scores. Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome). |
| Secondary | Between-groups difference in proportion of responders and remitters | Week 4 and 8 | Between-groups difference in proportion of responders and remitters with response and remission defined by HDS-6 score without clinical relevant manic symptoms (MAS \<7) at planned or premature endpoint. Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome). |
| Secondary | Between-groups difference in the proportion of patients with 'acceptable wellbeing' | up to 8 weeks | Between-groups difference in the proportion of patients with 'acceptable wellbeing', defined as the subject reporting ≥50 on the WHO-5 questionnaire at endpoint. WHO-five Well-being Index, WHO-5 (Values 0- 100, higher scores mean a better outcome). |
| Secondary | Between-groups difference in proportion of switches to mania/hypomania. | up to 8 weeks | Between-groups difference in proportion of switches to mania/hypomania with or without mixed features, defined as mania/hypomania after DSM-5 or symptoms requiring treatment (switch or response occurring at any time in the study period) |
| Secondary | Between-groups difference in "(switch to mania or hypomania) / (response) -ratio", | up to 8 weeks | Between-groups difference in "(switch to mania or hypomania) / (response) -ratio", defined as the number of subjects switching to mania or hypomania (as defined above) divided by the total number of responders, including those responders switching to mania |
| Secondary | Between-group differences in reason for and time to all cause treatment discontinuation | up to 8 weeks | Between-group differences in reason for and time to all cause treatment discontinuation (lack of effect, lack of tolerability, lost to follow-up, or other cause). |
| Secondary | Between-group difference in treatment compliance. | up to 8 weeks | Between-group difference in treatment compliance. Treatment compliance is defined as the proportion of received treatments out of the planned until drop-out or end of study. |
| Secondary | Between-group difference in reasons for premature discontinuation | up to 8 weeks | Between-group difference for the ITT population in reasons for premature discontinuation |
| Secondary | Difference-in-difference for MAS | Week 4 and 8 | Difference-in-differences for secondary continuous measures: MAS Bech-Rafaelsens Mania scale .(Values 0- 44, higher scores mean a worse outcome). |
| Secondary | Difference-in-difference for MES | Week 4 and 8 | Difference-in-differences for secondary continuous measures: MES Bech-Rafaelsens Melancholia scale, MES .(Values 0- 44, higher scores mean a worse outcome). |
| Secondary | Difference-in-differences for MADRS | Week 4 and 8 | Difference-in-differences for secondary continuous measures: MADRS Montgomery-Aaberg Depression Rating Scale, MADRS .(Values 0- 60, higher scores mean a worse outcome). |
| Secondary | Difference-in-difference for YMRS | Week 4 and 8 | Difference-in-differences for secondary continuous measures:YMRS Young Mania Rating Scale, YMRS .(Values 0- 60, higher scores mean a worse outcome). |
| Secondary | Difference-in-differences for ASRM-14 | Week 4 and 8 | Difference-in-differences for secondary continuous measures:ASRM-14 Altman Self-Rating Mania Scale-14, .(Values 0- 56, higher scores mean a worse outcome). |
| Secondary | Difference-in-differences for MDI | Week 4 and 8 | Difference-in-differences for secondary continuous measures:MDI Major Depression Inventory, MDI (Values 0- 58, higher scores mean a worse outcome). |
| Secondary | Difference-in-differences for WHO-5 questionnaire | Week 4 and 8 | Difference-in-differences for secondary continuous measures: WHO-5 questionnaire. WHO-five Well-beeing Index, WHO-5 (Values 0- 100, higher scores mean a better outcome). |
| Secondary | Difference-in-difference for SCIP | Week 8 | Difference-in-differences for secondary continuous measures: SCIP Screen for Cognitive Impairment in Psychiatry, SCIP (Values 0- 64+, higher scores mean a better outcome) |
| Secondary | Difference-in-difference for COBRA | Week 8 | Difference-in-differences for secondary continuous measures: COBRA Cognitive complaints in bipolar disorder Ratings assessment, COBRA, (Values 0- 48, higher scores mean a worse outcome). |
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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