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

NCT05913947 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Depression, Bipolar

Interventions

DRUG

Lithium

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.

DRUG

Cariprazine

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.

Sponsors & Collaborators

  • Mental Health Center, Glostrup

    collaborator UNKNOWN

  • Mental Health Department Odense, University Clinic

    collaborator UNKNOWN

  • Psychiatric Center Copenhagen, Rigshospitalet

    collaborator UNKNOWN

  • Psychiatric Hospital, Hillerod

    collaborator OTHER

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • René E. Nielsen, Prof, MD,PhD · Psychiatry, Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2028-09-01
Completion
2028-09-02

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05913947 on ClinicalTrials.gov