Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
ConditionDepression, Bipolar
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAalborg University Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lithium
- Cariprazine
Treatment groups
122 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aalborg University Hospital
Lead sponsor
Glostrup University Hospital, Copenhagen
Collaborator
Mental Health Department Odense, University Clinic
Collaborator
Psychiatric Center Copenhagen, Rigshospitalet
Collaborator
Psychiatric Hospital, Hillerod
Collaborator
Source ClinicalTrials.gov