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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lithium
DrugThe 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.
Cariprazine
DrugThe 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.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: LithiumExperimental treatment 1 intervention
Group B: CariprazineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hamilton Depressions scale, version 6 (HDS-6)
The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).
Time frame
8 weeksSecondary outcomes
1
Difference-in-difference for HDS-17
Difference-in-differences for secondary continuous measures: Hamilton Depression Scale, 17 item version, HDS-17. (Values 0- 52, higher scores mean a worse outcome)
Time frame
Week 4 and 82
Difference-in-differences in HDS-6 for the PP 8 population
Difference-in-differences (baseline to 8 weeks) in HDS-6 for the PP 8 population. Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).
Time frame
8 weeks3
Between-groups difference in proportion of responders and remitters in HDS-6 Scores.
Between-groups difference in proportion of responders and remitters at week 4 and 8 in HDS-6 scores. Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).
Time frame
Week 4 and week 84
Between-groups difference in proportion of responders and remitters
Between-groups difference in proportion of responders and remitters with response and remission defined by HDS-6 score without clinical relevant manic symptoms (MAS \<7) at planned or premature endpoint. Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).
Time frame
Week 4 and 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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