BridgeMD
Compares treatment options for Depression, Bipolar
Official title Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
ClinicalTrials.gov ID: NCT05913947
What this study is testing
What is Lithium?
Lithium is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for depression, bipolar.
Also referred to as Litarex, ATC; N05AN01.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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))...
- No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.
- Age criteria: people must be at least 18 years old and below 65 at the time of randomization.
You likely can't join if
- 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
See the full eligibility 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: people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.