Comparing lithium and cariprazine for treating bipolar depression

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)

This study is testing whether lithium or cariprazine works better for treating depression in people with bipolar disorder.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 122 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Aalborg University Hospital (other)
• Locations: 1 site (Aalborg)
• Trial ID: NCT05913947 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of lithium and cariprazine in treating patients with bipolar disorder who are experiencing a depressive episode. Participants will be randomly assigned to receive either lithium or cariprazine for eight weeks, with their progress measured using the Hamilton Depression Scale, 6-item version (HDS-6). Throughout the study, participants will attend multiple in-person assessments and provide blood and urine samples, as well as participate in telephone interviews to monitor their symptoms and overall well-being.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of bipolar disorder type 1 or 2 currently experiencing a depressive episode.

Not a fit: Patients with bipolar disorder who are not currently experiencing a depressive episode or those who have recently changed their psychotropic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with bipolar depression.

How similar studies have performed: Previous studies have explored the efficacy of lithium and cariprazine separately, but this direct comparison in the acute treatment of bipolar depression is relatively novel.

Eligibility criteria

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
* 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.

Where this trial is running

Aalborg

• Aalborg University Hospital — Aalborg, Denmark (RECRUITING)

Study contacts

• Principal investigator: René E. Nielsen, Prof, MD,PhD — Psychiatry, Aalborg University Hospital
• Study coordinator: Sanne V. Hovgesen, MD

Conditions: Depression, Bipolar