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

Conditions

Depression Bipolar

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

Inclusion Criteria9

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 Criteria12

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.

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.