RecruitingPhase 4NCT05913947

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

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)

Sponsor

Aalborg University Hospital

Enrollment

122 participants

Start Date

Dec 13, 2022

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study (DUAG9) is comparing two medications — lithium and cariprazine — to see which works better for treating depression in people with bipolar disorder (either type 1 or type 2). **You may be eligible if...** - You have bipolar disorder (type 1 or 2) and are currently in a depressive episode - Your depression score is 21 or higher on the MDI (Major Depression Inventory) self-report - You have not recently started or increased any psychiatric medication (except for sleep) - You are 18 or older **You may NOT be eligible if...** - You are currently in a manic or mixed episode - You have a current serious risk of suicide requiring immediate hospitalization - You have had no response to both lithium and cariprazine before - You are pregnant or breastfeeding - You have significant kidney or thyroid problems (which can be affected by lithium) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLithium

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.

DRUGCariprazine

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.

Locations(1)

Aalborg University Hospital

Aalborg, Denmark

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NCT05913947