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

Sponsor
Aalborg University Hospital
Study ID
NCT05913947
Phase
PHASE4
Status
Recruiting
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Conditions

  • Depression, Bipolar

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lithium — DRUG
    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.
  • Cariprazine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 13, 2022
Status verified
Jan 2025
Primary completion
Sep 1, 2028
Completion
Sep 2, 2028

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lithium
    Lithium citrate from 12 mmol increased to result in af 12-hour se-lithium between 0.6 and 0.8 mmol/l
  • Experimental: Cariprazine
    Cariprazine from 1.5 mg to 3 mg daily in a single dose.

Primary Outcome Measure

Change in Hamilton Depressions scale, version 6 (HDS-6) [ Time Frame: 8 weeks ]

Central Contacts

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