Bipolar DisorderNCT04229875
The CAG Bipolar the CAG Bipolar RCT
A study testing CAG Bipolar in people with Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- CAG Bipolar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jan 2020to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a main diagnosis of bipolar disorder in the five largest psychiatric centers in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hillerød, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup) will be asked for participation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Psychiatric Center Copenhagen
Copenhagen, 2100
Lars V Kessing, Professor, 38647081 ext. 0045, lars.vedel.kessing@regionh.dk
Maria Faurholt-Jepsen, MD, DMSc, 38647073 ext. 0045, maria.faurholtjepsen@regionh.dk
About this study
Official title: Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients).
Read the detailed description
Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. Traditionally, psychiatry has been sparsely subspecialized in Denmark as well as internationally during the last four decades leaving patients in generalized psychiatric settings. At the same time, demands to clinical skills, research and education have increased, and IT solutions have emerged as a possible way to optimize treatment.
Effects of organizational changes and digital health interventions are rarely investigated scientifically in health care services. This is a randomized controlled trial conducted in the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region.
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients). Findings from the study will have great impact on future organization and optimization of treatment within psychiatry in Denmark as well as internationally.
- Conditions
- Bipolar Disorder
- Being tested
- CAG Bipolar
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAG BipolarOther
See description of CAG Bipolar
| Study group | Role | What they receive |
|---|---|---|
| CAG Bipolar | Experimental | 1. Patients will be treated in a localized CAG Bipolar clinic within each psychiatric centre increasing the number of bipolar patients for each clinician
2. All clinicians will get certified in diagnosing and treating bipolar disorder by joining an educational course and ongoing courses continuously
3. Treatment will include a group-based psychoeducation program
4. Coordinated targets to improve quality of life of patients by increasing concordance between clinicians, patients and relatives on well-defined treatment goals
5. Continued ongoing supervision of patient cases in CAG Bipolar staff by the Copenhagen Affective Disorder Clinic
6. Three-month bidirectional exchange of two clinical staff members between the Copenhagen Affective Disorder Clinic and each CAG Bipolar clinic
7. Recovery mentors Receives: Other: CAG Bipolar |
| Control group | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of psychiatric hospitalization
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
Measured: During the entire study period of 12 months pr participant
Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register
Data on cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
Measured: During the entire study period of 12 months pr participant
Secondary outcomes (9)
Quality of life according to WHO Quality of Life-BREF (WHOQoL)
Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
Measured: Baseline, 6 months and 12 months
Perceived stress according to Cohen's Perceived stress scale
Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
Measured: Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Measured: Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Measured: Baseline, 6 months and 12 months
Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine
Data collected from electronic patient records.
Measured: During the entire study period of 12 months per participant
Clinicians' satisfaction with their work at start and end of the RCT
Clinician evaluated using the Medical Personnel Job Satisfaction Questionnaire
Measured: Baseline and 12 months
Patient-reported depressive symptoms according to the major depressive Inventory (MDI)
Patient-evaluated. Higher scores indicate higher level of depressive symptoms.
Measured: Baseline, 6 months and 12 months
Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM)
Patient-evaluated. Higher scores indicate higher level of manic symptoms.
Measured: Baseline, 6 months and 12 months
Proportion of patients starting group-based psychoeducation
Proportion of patients in clinics starting in group-based psychoeducation
Measured: During the entire study period of 12 months per centre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Jan 2020
- Primary completion13 Nov 2023 (estimated)
- Study completion13 Jan 2025 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark
- Responsible party
- Principal investigator, Lars Vedel Kessing, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229875
- Sponsor's protocol ID
- H-19067248
- Status last verified
- Mar 2023
- First submitted
- 3 Jan 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swieczkowski 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 41401709Kessing LV, Kyster NB, Bondo-Kozuch P, Christensen EM, Vejstrup B, Smidt B, Jorgensen AB, Rosenberg R, Mardosas D, Rasmussen LB, Vinberg M, Hageman I, Faurholt-Jepsen M; CAG Bipolar Study group. Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 13;11(10):e048821. doi: 10.1136/bmjopen-2021-048821.
PubMed 34645661
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT
- ClinicalTrials.gov ID
- NCT04229875
- Acronym / sponsor ID
- H-19067248
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 13 Nov 2023 (estimated)
- Study completion
- 13 Jan 2025 (estimated)
- First posted
- 18 Jan 2020 (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 CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients).
Detailed description
Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. Traditionally, psychiatry has been sparsely subspecialized in Denmark as well as internationally during the last four decades leaving patients in generalized psychiatric settings. At the same time, demands to clinical skills, research and education have increased, and IT solutions have emerged as a possible way to optimize treatment.
Effects of organizational changes and digital health interventions are rarely investigated scientifically in health care services. This is a randomized controlled trial conducted in the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region.
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients). Findings from the study will have great impact on future organization and optimization of treatment within psychiatry in Denmark as well as internationally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAG Bipolar | Experimental | Other: CAG Bipolar1. Patients will be treated in a localized CAG Bipolar clinic within each psychiatric centre increasing the number of bipolar patients for each clinician 2. All clinicians will get certified in diagnosing and treating bipolar disorder by joining an educational course and ongoing courses continuously 3. Treatment will include a group-based psychoeducation program 4. Coordinated targets to improve quality of life of patients by increasing concordance between clinicians, patients and relatives on well-defined treatment goals 5. Continued ongoing supervision of patient cases in CAG Bipolar staff by the Copenhagen Affective Disorder Clinic 6. Three-month bidirectional exchange of two clinical staff members between the Copenhagen Affective Disorder Clinic and each CAG Bipolar clinic 7. Recovery mentors |
| Control group | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a main diagnosis of bipolar disorder in the five largest psychiatric centers in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hillerød, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup) will be asked for participation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CAG BipolarSee description of CAG Bipolar | Other | CAG Bipolar |
Primary outcome
Risk of psychiatric hospitalization
Time frame: During the entire study period of 12 months pr participant
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register
Time frame: During the entire study period of 12 months pr participant
Data on cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
9 secondary outcomes
Quality of life according to WHO Quality of Life-BREF (WHOQoL)
Time frame: Baseline, 6 months and 12 months
Perceived stress according to Cohen's Perceived stress scale
Time frame: Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Time frame: Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire
Time frame: Baseline, 6 months and 12 months
Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine
Time frame: During the entire study period of 12 months per participant
Clinicians' satisfaction with their work at start and end of the RCT
Time frame: Baseline and 12 months
Patient-reported depressive symptoms according to the major depressive Inventory (MDI)
Time frame: Baseline, 6 months and 12 months
Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM)
Time frame: Baseline, 6 months and 12 months
Proportion of patients starting group-based psychoeducation
Time frame: During the entire study period of 12 months per centre
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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.
- Derived from this study: PubMed 34645661Kessing LV, Kyster NB, Bondo-Kozuch P, Christensen EM, Vejstrup B, Smidt B, Jorgensen AB, Rosenberg R, Mardosas D, Rasmussen LB, Vinberg M, Hageman I, Faurholt-Jepsen M; CAG Bipolar Study group. Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 13;11(10):e048821. doi: 10.1136/bmjopen-2021-048821.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAG Bipolar in people with Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Vedel Kessing, Prof., MD, DMSc (+4538647073, 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?
Risk of psychiatric hospitalization (time frame: During the entire study period of 12 months pr participant). The study lists 2 primary outcomes in all. 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 NCT04229875, 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 16 Mar 2023.