Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Lithium for Depression, Bipolar

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) you would be randomly assigned to treatment with either lithium or cariprazin.

Official registry: https://clinicaltrials.gov/study/NCT05913947 · Aalborg University Hospital · enrollment listed as 122

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lithium, or Cariprazine. The registry lists allocation as randomized. The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.

They plan to enroll about 122 people at Aalborg. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Lithium, Cariprazine

Primary outcome (registry wording): Change in Hamilton Depressions scale, version 6 (HDS-6)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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

Public study contact (from the registry)

Sanne V. Hovgesen, MD

+45 25487706

sanne.hovgesen@rn.dk

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05913947 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05913947?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05913947?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary