Bipolar II DisorderPhase 4LiLa-BipolarNCT06184581
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
A Phase 4 study testing Lithium Carbonate and Lamotrigine in people with Bipolar II Disorder, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar II Disorder
- What is being tested?
- Lithium Carbonate and Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 8 May 2024to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give informed consent)
Who cannot join
- Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- Currently taking mood stabilizers at enrollment in CADIC
- Severe chronic kidney disease
- Severe cardiac insufficiency
- Brugadas syndrome
- Severe hypothyroidism despite treatment
- Women who are pregnant, breastfeeding or planning pregnancy in near future.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Psychiatric Center Copenhagen
Copenhagen
Lars Vedel Kessing, professor, MD, DMSc., +45 38 64 70 81, lars.vedel.kessing@regionh.dk
About this study
Official title: Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
Read the detailed description
Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological treatment including the most frequently used drugs in clinical practice lithium and lamotrigine, is substantially understudied. The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
- Conditions
- Bipolar II Disorder
- Being tested
- Lithium Carbonate, Lamotrigine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
Also called lithium citrate
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
LamotrigineDrug
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | tablet Receives: Drug: Lithium Carbonate |
| Lamotrigine | Active comparator | tablet Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood stabilization
Mood Stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso app. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings.
Measured: 6 (possibility of 12) months follow-up
Secondary outcomes (2)
Non-response
Add-on of Quetiapin >100mg/day or another antipsychotic drug, antidepressant drug, or inverse drug during the RCT-period or change from the allocated drug to lithium or lamotrigine
Measured: 6 (possibility of 12) months follow-up
Depression
Clinically rated observer-based difference in depression scores over the six-month trial period on the Hamilton Depression Scale-6 items
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start8 May 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar II DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blinded two-armed, parallel randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Vedel Kessing, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184581
- Sponsor's protocol ID
- 2023-509607-32-00
- Other IDs
- 10.46540/2096-00007B, 2023
- Acronym
- LiLa-Bipolar
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fredskild MU, Fussing Bruun CF, Miskowiak KW, Budtz-Jorgensen E, Vinberg M, Faurholt-Jepsen M, Kessing LV. Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT). BMJ Open. 2026 May 8;16(5):e116196. doi: 10.1136/bmjopen-2026-116196.
PubMed 42103384Swieczkowski D, Kwasny A, Cubala WJ. Cross-sectional analysis of ongoing clinical trials involving lamotrigine for mental disorders: Insights from ClinicalTrials.gov and the EU clinical trials. Psychiatry Res. 2026 Feb;356:116878. doi: 10.1016/j.psychres.2025.116878. Epub 2025 Dec 4.
PubMed 41401709
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
- ClinicalTrials.gov ID
- NCT06184581
- Acronym / sponsor ID
- LiLa-Bipolar / 2023-509607-32-00
- Conditions
- Bipolar II Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
Detailed description
Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological treatment including the most frequently used drugs in clinical practice lithium and lamotrigine, is substantially understudied. The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-blinded two-armed, parallel randomized trial
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: Lithium Carbonatetablet |
| Lamotrigine | Active comparator | Drug: Lamotriginetablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give informed consent)
Key exclusion criteria (7 listed)
- Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- Currently taking mood stabilizers at enrollment in CADIC
- Severe chronic kidney disease
- Severe cardiac insufficiency
- Brugadas syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium CarbonateAlso: lithium citrateThe trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium. | Drug | Lithium |
| LamotrigineThe trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium. | Drug | Lamotrigine |
Primary outcome
Mood stabilization
Time frame: 6 (possibility of 12) months follow-up
Mood Stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso app. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings.
2 secondary outcomes
Non-response
Time frame: 6 (possibility of 12) months follow-up
Depression
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 42103384Fredskild MU, Fussing Bruun CF, Miskowiak KW, Budtz-Jorgensen E, Vinberg M, Faurholt-Jepsen M, Kessing LV. Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT). BMJ Open. 2026 May 8;16(5):e116196. doi: 10.1136/bmjopen-2026-116196.
- Derived from this study: PubMed 41401709Swieczkowski D, Kwasny A, Cubala WJ. Cross-sectional analysis of ongoing clinical trials involving lamotrigine for mental disorders: Insights from ClinicalTrials.gov and the EU clinical trials. Psychiatry Res. 2026 Feb;356:116878. doi: 10.1016/j.psychres.2025.116878. Epub 2025 Dec 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lithium Carbonate and Lamotrigine in people with Bipolar II Disorder, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Vedel Kessing, professor, MD, DMSc. (+45 38 64 70 81, lars.vedel.kessing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood stabilization (time frame: 6 (possibility of 12) months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.