Depression, BipolarPhase 4DUAG9NCT05913947
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
A Phase 4 study testing Lithium and Cariprazine in people with Depression, Bipolar, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease. The main question it aims to answer is: Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6) Participants… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Bipolar
- What is being tested?
- Lithium and Cariprazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Dec 2022to 2 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5
- Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
- No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion.
- No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.
- Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.
- The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization.
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- Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case.
- Female participants should be sterile or non-fertile or, in case of being fertile, they must have a negative pregnancy test AND use safe anticonception.
- Signed document of informed consent.
Who cannot join
- Prior or ongoing acute treatment of a depressive episode lasting > 14 days with either lithium or cariprazine as judged by the investigator.
- ECT within the current depressive episode.
- A score of MAS > 6.
- A diagnosis of dementia.
- High risk of non-adherence at the investigator's discretion.
- Not understanding the Danish language as judged by the investigator
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- Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care.
- Presence of clinically relevant delusions, hallucinations or other psychotic symptoms as judged by the investigator.
- Suicidality according to C-SSRS with a positive response to question 4 or 5 or upon investigator's discretion.
- Medical conditions like cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.
- Current harmful use or dependency of alcohol or drugs according to DSM-5.
- Known allergy to any of the substances in the study medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Sanne V. Hovgesen, MD, +45 29217805, sanne.hovgesen@rn.dk
Simon Johnsen, +45 61395631, simon.johnsen@rn.dk
About this study
Official title: Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)
The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.
The main question it aims to answer is:
Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6)
Participants will be randomized to treatment with either lithium or cariprazin.
- Will meet for interview and ratings 4 times during study period.
- In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample.
- Will be contacted for telephone interviews at 6 occasions.
Read the detailed description
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) from baseline to 8 weeks of treatment. Secondarily, we aimed at comparing the two study medications on various other clinically relevant variables.
These include depressive and manic symptomatology, sleep patterns, general well-being, cognitive function, social functioning and suicidal ideation.
- Conditions
- Depression, Bipolar
- Being tested
- Lithium, Cariprazine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Also called Litarex, ATC; N05AN01
The starting dose (day one) of lithium citrate is 12 mmol (one tablet of lithium citrate contains 6 mmol lithium) given once a day before bedtime. On day three the dose is increased to 18 mmol. Dose adjustments are permitted after 7 days in a flexible manner to result in a 12-hour se-lithium between 0.6 and 0.8 mmol/l, aiming for the upper limit at the treating physician's discretion.
CariprazineDrug
Also called Reagila, ATC: N05AX15
The starting dose for cariprazine is 1.5 mg daily in a single dose, and subsequently, after a minimum of two weeks, the dose can be increased to 3 mg and decreased again to 1.5 mg daily at the treating physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | Lithium citrate from 12 mmol increased to result in af 12-hour se-lithium between 0.6 and 0.8 mmol/l Receives: Drug: Lithium |
| Cariprazine | Experimental | Cariprazine from 1.5 mg to 3 mg daily in a single dose. Receives: Drug: Cariprazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depressions scale, version 6 (HDS-6)
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).
Measured: 8 weeks
Secondary outcomes (31)
Difference-in-difference for HDS-17
Difference-in-differences for secondary continuous measures: Hamilton Depression Scale, 17 item version, HDS-17. (Values 0- 52, higher scores mean a worse outcome)
Measured: Week 4 and 8
Difference-in-differences in HDS-6 for the PP 8 population
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).
Measured: 8 weeks
Between-groups difference in proportion of responders and remitters in HDS-6 Scores.
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).
Measured: Week 4 and week 8
Between-groups difference in proportion of responders and remitters
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).
Measured: Week 4 and 8
Between-groups difference in the proportion of patients with 'acceptable wellbeing'
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).
Measured: up to 8 weeks
Between-groups difference in proportion of switches to mania/hypomania.
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)
Measured: up to 8 weeks
Between-groups difference in "(switch to mania or hypomania) / (response) -ratio",
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
Measured: up to 8 weeks
Between-group differences in reason for and time to all cause treatment discontinuation
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).
Measured: up to 8 weeks
Between-group difference in treatment compliance.
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.
Measured: up to 8 weeks
Between-group difference in reasons for premature discontinuation
Between-group difference for the ITT population in reasons for premature discontinuation
Measured: up to 8 weeks
Difference-in-difference for MAS
Difference-in-differences for secondary continuous measures: MAS Bech-Rafaelsens Mania scale .(Values 0- 44, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for MES
Difference-in-differences for secondary continuous measures: MES Bech-Rafaelsens Melancholia scale, MES .(Values 0- 44, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-differences for MADRS
Difference-in-differences for secondary continuous measures: MADRS Montgomery-Aaberg Depression Rating Scale, MADRS .(Values 0- 60, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for YMRS
Difference-in-differences for secondary continuous measures:YMRS Young Mania Rating Scale, YMRS .(Values 0- 60, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-differences for ASRM-14
Difference-in-differences for secondary continuous measures:ASRM-14 Altman Self-Rating Mania Scale-14, .(Values 0- 56, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-differences for MDI
Difference-in-differences for secondary continuous measures:MDI Major Depression Inventory, MDI (Values 0- 58, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-differences for WHO-5 questionnaire
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).
Measured: Week 4 and 8
Difference-in-difference for SCIP
Difference-in-differences for secondary continuous measures: SCIP Screen for Cognitive Impairment in Psychiatry, SCIP (Values 0- 64+, higher scores mean a better outcome)
Measured: Week 8
Difference-in-difference for COBRA
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).
Measured: Week 8
Difference-in-difference for FAST
Difference-in-differences for secondary continuous measures: FAST Functioning Assessment Short Test, FAST (Values 0 - 72, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for PSQI
Difference-in-differences for secondary continuous measures:PSQI PIttsburgh Sleep Quality Index, PSQI (Values 0 - 21, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for CGI-S
Difference-in-differences for secondary continuous measures: CGI-S Clinical Global Impression Scale - Severity, CGI-S (Values 1 -7, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for CGI-I
Difference-in-differences for secondary continuous measures:CGI-I Clinical Global Impression Scale - Global Improvement CGI- I (Values 1 -7, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for C-SSRS
Difference-in-differences for secondary continuous measures: C-SSRS Columbia-Suicide Severity Rating Scale, C-SSRS (Values 1 - 5, higher scores mean a worse outcome).
Measured: Week 4 and 8
Difference-in-difference for accumulated benzodiazepine dose
Difference-in-differences for secondary continuous measures: accumulated benzodiazepine dose as diazepam equivalents (DSKP)
Measured: Up to 8 weeks
Difference-in-difference for time to all-causes discontinuation
Difference-in-differences for secondary continuous measures: for time to all-causes discontinuation
Measured: Up to 8 weeks
Difference-in-difference for time to all-causes. all-causes study endpoint.
Difference-in-differences for secondary continuous measures: all-causes study endpoint.
Measured: Up to 8 weeks
Between-group difference in reasons for time to all cause discontinuation.
Between-group difference for the ITT population in reasons for time to all cause discontinuation.
Measured: Up to 8 weeks
Between-group difference in reasons for treatment expectation.
Between-group difference for the ITT population in reasons for treatment expectation.
Measured: Up to 8 weeks
Between-group difference in reasons for adverse events.
Between-group difference for the ITT population in reasons for adverse events.
Measured: Up to 8 weeks
Between-group difference in reasons for serious adverse events.
Between-group difference for the ITT population in reasons for serious adverse events.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Dec 2022
- Primary completion1 Sep 2028 (estimated)
- Study completion2 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, BipolarStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Mental Health Department Odense, University Clinic, Psychiatric Center Copenhagen, Rigshospitalet, Psychiatric Hospital, Hillerod
- Responsible party
- Principal investigator, René Ernst Nielsen, Aalborg University Hospital
- Investigators
- René E. Nielsen, Prof, MD,PhD, Principal investigator, Psychiatry, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913947
- Sponsor's protocol ID
- 2021-006706-69
- Acronym
- DUAG9
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hovgesen SV, Licht RWW, Straszek SPV, Christensen AE, Vinberg M, Videbech P, Miskowiak KW, Johnsen S, Munk MM, Mai ML, Baethge C, Kessing LV, Nielsen RE. Lithium versus cariprazine in the acute phase treatment for depressive episodes in patients with bipolar disorder: a protocol for a pragmatic open, randomised multicentre study - the 9th trial of the Danish University Antidepressant Group, DUAG-9. BMJ Open. 2025 Aug 27;15(8):e102406. doi: 10.1136/bmjopen-2025-102406.
PubMed 40866064
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)
- ClinicalTrials.gov ID
- NCT05913947
- Acronym / sponsor ID
- DUAG9 / 2021-006706-69
- Conditions
- Depression, Bipolar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Mental Health Department Odense, University Clinic, Psychiatric Center Copenhagen, Rigshospitalet, Psychiatric Hospital, Hillerod
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 2 Sep 2028 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.
The main question it aims to answer is:
Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6)
Participants will be randomized to treatment with either lithium or cariprazin.
- Will meet for interview and ratings 4 times during study period.
- In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample.
- Will be contacted for telephone interviews at 6 occasions.
Detailed description
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) from baseline to 8 weeks of treatment. Secondarily, we aimed at comparing the two study medications on various other clinically relevant variables.
These include depressive and manic symptomatology, sleep patterns, general well-being, cognitive function, social functioning and suicidal ideation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: LithiumLithium citrate from 12 mmol increased to result in af 12-hour se-lithium between 0.6 and 0.8 mmol/l |
| Cariprazine | Experimental | Drug: CariprazineCariprazine from 1.5 mg to 3 mg daily in a single dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5
- Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
- No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion.
- No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.
- Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.
Key exclusion criteria (12 listed)
- Prior or ongoing acute treatment of a depressive episode lasting > 14 days with either lithium or cariprazine as judged by the investigator.
- ECT within the current depressive episode.
- A score of MAS > 6.
- A diagnosis of dementia.
- High risk of non-adherence at the investigator's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LithiumAlso: Litarex, ATC; N05AN01The starting dose (day one) of lithium citrate is 12 mmol (one tablet of lithium citrate contains 6 mmol lithium) given once a day before bedtime. On day three the dose is increased to 18 mmol. Dose adjustments are permitted after 7 days in a flexible manner to result in a 12-hour se-lithium between 0.6 and 0.8 mmol/l, aiming for the upper limit at the treating physician's discretion. | Drug | Lithium |
| CariprazineAlso: Reagila, ATC: N05AX15The starting dose for cariprazine is 1.5 mg daily in a single dose, and subsequently, after a minimum of two weeks, the dose can be increased to 3 mg and decreased again to 1.5 mg daily at the treating physician's discretion. | Drug | Cariprazine |
Primary outcome
Change in Hamilton Depressions scale, version 6 (HDS-6)
Time frame: 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).
31 secondary outcomes
Difference-in-difference for HDS-17
Time frame: Week 4 and 8
Difference-in-differences in HDS-6 for the PP 8 population
Time frame: 8 weeks
Between-groups difference in proportion of responders and remitters in HDS-6 Scores.
Time frame: Week 4 and week 8
Between-groups difference in proportion of responders and remitters
Time frame: Week 4 and 8
Between-groups difference in the proportion of patients with 'acceptable wellbeing'
Time frame: up to 8 weeks
Between-groups difference in proportion of switches to mania/hypomania.
Time frame: up to 8 weeks
Between-groups difference in "(switch to mania or hypomania) / (response) -ratio",
Time frame: up to 8 weeks
Between-group differences in reason for and time to all cause treatment discontinuation
Time frame: up to 8 weeks
Between-group difference in treatment compliance.
Time frame: up to 8 weeks
Between-group difference in reasons for premature discontinuation
Time frame: up to 8 weeks
Difference-in-difference for MAS
Time frame: Week 4 and 8
Difference-in-difference for MES
Time frame: Week 4 and 8
Difference-in-differences for MADRS
Time frame: Week 4 and 8
Difference-in-difference for YMRS
Time frame: Week 4 and 8
Difference-in-differences for ASRM-14
Time frame: Week 4 and 8
Difference-in-differences for MDI
Time frame: Week 4 and 8
Difference-in-differences for WHO-5 questionnaire
Time frame: Week 4 and 8
Difference-in-difference for SCIP
Time frame: Week 8
Difference-in-difference for COBRA
Time frame: Week 8
Difference-in-difference for FAST
Time frame: Week 4 and 8
Difference-in-difference for PSQI
Time frame: Week 4 and 8
Difference-in-difference for CGI-S
Time frame: Week 4 and 8
Difference-in-difference for CGI-I
Time frame: Week 4 and 8
Difference-in-difference for C-SSRS
Time frame: Week 4 and 8
Difference-in-difference for accumulated benzodiazepine dose
Time frame: Up to 8 weeks
Difference-in-difference for time to all-causes discontinuation
Time frame: Up to 8 weeks
Difference-in-difference for time to all-causes. all-causes study endpoint.
Time frame: Up to 8 weeks
Between-group difference in reasons for time to all cause discontinuation.
Time frame: Up to 8 weeks
Between-group difference in reasons for treatment expectation.
Time frame: Up to 8 weeks
Between-group difference in reasons for adverse events.
Time frame: Up to 8 weeks
Between-group difference in reasons for serious adverse events.
Time frame: Up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 40866064Hovgesen SV, Licht RWW, Straszek SPV, Christensen AE, Vinberg M, Videbech P, Miskowiak KW, Johnsen S, Munk MM, Mai ML, Baethge C, Kessing LV, Nielsen RE. Lithium versus cariprazine in the acute phase treatment for depressive episodes in patients with bipolar disorder: a protocol for a pragmatic open, randomised multicentre study - the 9th trial of the Danish University Antidepressant Group, DUAG-9. BMJ Open. 2025 Aug 27;15(8):e102406. doi: 10.1136/bmjopen-2025-102406.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
René E. Nielsen, Prof, MD,PhD principal investigator
Psychiatry, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lithium and Cariprazine in people with Depression, Bipolar, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanne V. Hovgesen, MD (+45 25487706, sanne.hovgesen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depressions scale, version 6 (HDS-6) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.