Trial · NCT05913947
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
NCT05913947, Phase 4, Recruiting, Aalborg University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9). Trials, record NCT05913947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05913947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
- NCT number
- NCT05913947
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 122 participants, estimated
- Lead sponsor
- Aalborg University Hospital
- Conditions
- Depression, Bipolar
- Interventions
- Lithium, Cariprazine
- First posted
- 2023-06-22
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40866064 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05913947
GET https://conductscience.org/api/trials/v1/NCT05913947/registered?page=2