Sema.Mood

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

15 May 2025 → ongoing

Decision date (initial)

2025-05-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Psykiatrisk Center Nordsjælland

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Primary outcome. The primary endpoint is the change in depressive symptoms measured as the difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI)48 from week 0 to week 26. MDI estimates depression symptom severity and the patients will rate how much time in the past two weeks each of the symptoms of the depressive syndrome is present

Secondary objectives 1

1. Secondary outcomes. Changes in body weight. Inflammatory, metabolomics and oxidative stress biomarkers. Global functioning, cognition, and Quality of Life

Conditions and MedDRA coding

Unipolar depression Overweight and obesity

Regulatory references

Plan to share IPD

No

IPD plan description

All individual participants' data will be anonymised

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Informed oral and written consent. 2. Diagnosed with unipolar disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association 3. Hamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥13, 4. Age 18 years to 70 years (both included) 5. Body mass index (BMI) ≥27 kg/m2

Exclusion criteria 1

1. 1. Any significant medical disorder or conditions that contraindicate the investigational drug, e.g., pregnancy, presence of known allergy GLP-1 receptor agonists, severe neurological disorder, diabetes I, on-going drug, or alcohol abuse 2. Coercive measures 3. Females of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant 4. Women who are not willing to use an adequate contraceptive during the full length of the study 5. Patients treated with corticosteroids or other hormone therapy (except oestrogens). 6. Any active substance abuse or dependence (except for nicotine) 7. Impaired hepatic function (plasma liver transaminases >2 times upper normal limit). 8. Impaired renal function (serum creatinine >150 μmol/l) 9. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit) 10. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months 11. Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg 12. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit). Receiving any experimental or pre-marketing drug within the last 3 months 13. Use of diabetes medication or weight-lowering pharmacotherapy within the preceding 3 months 14. Known type 1 and 2 diabetes or HbA1c>48mmol/mol 15. No glucose-lowering medication is allowed for the trial 16. Suicidal behaviour as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (except DXA scanning visits, please see Table 1) possible suicidality will be evaluated according to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action 17. Any condition that the investigator feels would interfere with trial participation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome will be change in Major Depression Inventory from baseline to end of study

Secondary endpoints 1

1. Secondary outcomes include changes in body weight, hip and waist circumference, hemoglobin A1c lean and fat body mass and bone density, biomarkers related to inflammation, and oxidative stress and further overall functioning, quality of life, perceived stress, and cognitive scores

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Dyrehavevej 29

City

Hilleroed

Postcode

3400

Country

Denmark

Scientific contact point

Organisation

Psykiatrisk Center Nordsjaelland

Contact name

Vinberg Maj

Public contact point

Organisation

Psykiatrisk Center Nordsjaelland

Contact name

Vinberg Maj

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications