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RECRUITING

NCT05913947

PHASE4

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

Sponsor: Aalborg University Hospital

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2022-12-13

Completion Date

2028-09-02

Last Updated

2026-01-21

Healthy Volunteers

Conditions

Depression, Bipolar

Interventions

DRUG

Lithium

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.

DRUG

Cariprazine

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.

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.

Locations (1)

Aalborg University Hospital

Aalborg, Denmark