RecruitingPhase 4

Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)

Denmark122 participantsStarted 2022-12-13

Plain-language 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 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hamilton Depressions scale, version 6 (HDS-6)

Timeframe: 8 weeks

Trial details

NCT IDNCT05913947

SponsorAalborg University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Sanne V. Hovgesen, MD

+45 25487706 sanne.hovgesen@rn.dk

View on ClinicalTrials.gov More Depression, Bipolar trials