Major Depressive DisorderPhase 4SEMAMOODNCT07136714
Does Semaglutide Improve Depressive Symptoms in Patients With Major Depressive Disorder and Overweight or Obesity
A Phase 4 study testing Semaglutide Injectable Product in people with Major Depressive Disorder, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of semaglutide once-weekly vs. placebo on depressive symptoms in 116 patients with Major Depressive Disorder (MDD) and co-existing overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Semaglutide Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Sep 2025to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed oral and written consent.
- 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
- Hamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥14,
- Age 18 years to 65 years (both included)
- Body mass index (BMI) ≥27 kg/m2
- Able to speak and understand Danish
Who cannot join
- 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, on-going drug, or alcohol abuse
- Coercive measures
- Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus two months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device - IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
- Patients treated with corticosteroids or other hormone therapy (except oestrogens).
- Any active substance abuse or dependence (except for nicotine)
- Impaired hepatic function (plasma liver transaminases >2 times upper normal limit).
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- Impaired renal function (serum creatinine >150 μmol/l)
- Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
- Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
- 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
- Use of diabetes medication or weight-lowering pharmacotherapy e.g. semagultid within the preceding 3 months
- Known type 1 and 2 diabetes or HbA1c>48mmol/l
- Suicidal behaviour as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (please see Table 1) possible suicidality will be evaluatedaccording 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.
- Any condition that the investigator feels would interfere with trial participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christoffer Stanislaus, MD, ph.d.-student contact
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre North Zealand
Hillerød, Denmark, 3400
Maj Vinberg, MD, DMSc, Professor, +45 38643227, Maj.Vinberg@regionh.dk
Christoffer Stanislaus, MD, ph.d.-student
About this study
Official title: Is the GLP-1 Receptor Agonist Semaglutide Able to Alleviate Mood in Patients With Major Depressive Disorder and Overweight or Obesity
This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of semaglutide once-weekly vs. placebo on depressive symptoms in 116 patients with Major Depressive Disorder (MDD) and co-existing overweight or obesity. The treatment will be an add-on treatment to the patient's usual medication. The investigators hypothesize that adjunctive treatment with semaglutide, will lead to a significant improvement in mood compared to placebo in patients with MDD and overweight or obesity.
The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from start to follow-up after 26 weeks. The MDI measures the extent to which symptoms of depression have been present in the past two weeks.
Read the detailed description
This 26 week, randomized, double-blinded, placebo-controlled clinical trial investigate effects of semaglutide once-weekly vs. placebo on depressive symptoms in patients with unipolar disorder and comorbid obesity or overweight aged 18 years to 65 years. The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from week 0 to week 26.
Participants will be randomized to receive once-weekly injection of either semaglutide or placebo.
Patients will be treated for 26 weeks with an initial dose of semaglutide of 0.25 mg once weekly for four weeks, 0.50 mg once weekly for four weeks 1.0 mg for four weeks, 1.7 mg for four weeks and finally 2.4 mg for the remaining treatment period. Assessments will be conducted at weeks 0, 4, 8, 12, 16, 20, 24, and 26. Adherence and adverse events will be assessed during the entire treatment period. In addition, heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. The diagnosis of depression will be confirmed at baseline and depressive symptoms will be assessed with Hamilton Depression Rating Scale (HAM-D17) at baseline week 0, 12 and 26. MDI will be completed monthly. Participants will also complete questionnaires on physical activity, cognitive complaints, perceived stress, the reward system, Quality of life, alcohol use, and sleep quality at baseline and week 26.
- Conditions
- Major Depressive Disorder
- Being tested
- Semaglutide Injectable Product, Placebo
- Keywords
- GLP-1, Glucagon-like peptide 1, Semaglutide, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Injectable ProductDrug
Semaglutide (Wegovy) once-weekly injection s.c
PlaceboDrug
Placebo (BD Posiflush) once-weekly injection s.c
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Wegovy once--weekly s.c titrated to max dose of 2.4 mg Receives: Drug: Semaglutide Injectable Product |
| Placebo | Placebo comparator | Saline s.c. once-weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms
Change in depressive symptoms measured by the Major Depression Inventory (MDI; 12-item self-report mood questionnaire). The scale ranges from 0 to 50, with higher scores indicating worse outcome.
Measured: From baseline to 26 weeks of treatment
Secondary outcomes (5)
Glycaemic control parameters (blood sampling)
Changes in HbA1c levels
Measured: From baseline to 26 weeks of treatment
Body weight
Change in body weight in kilograms (kg).
Measured: From baseline to 26 weeks
Waist circumference
Change in waist circumference in centimeters (cm).
Measured: From baseline to 26 weeks of treatment
Hamilton Depression Rating Scale, 17-items (HDRS-17) score
Change in depressive symptoms measured by the Hamilton Depression Rating Scale, 17-items (HDRS-17) score. The scale ranges from 0 to 52, with higher scores indicating worse outcome.
Measured: From baseline to 26 weeks of treatment
Functioning assessment short test (FAST) score
Changes in Functioning assessment short test (FAST) score. Total score in the range 0-72, where higher scores reflect more serious functional impairment
Measured: From baseline to 26 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start11 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maj Vinberg, Nordsjaellands Hospital
- Investigators
- Maj Vinberg, MD, PhD, DMSc, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136714
- Sponsor's protocol ID
- 2024-511734-13-04
- Other IDs
- 2024-511734-13-04
- Acronym
- SEMAMOOD
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared upon reasonable and relevant requests, such as for meta-analyses. All IPD will be anonymized or de-identified to protect participants' privacy and in accordance with applicable regulations, including the GDPR.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the GLP-1 Receptor Agonist Semaglutide Able to Alleviate Mood in Patients With Major Depressive Disorder and Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07136714
- Acronym / sponsor ID
- SEMAMOOD / 2024-511734-13-04
- Conditions
- Major Depressive Disorder
- Keywords
- GLP-1, Glucagon-like peptide 1, Semaglutide, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Aug 2025 (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.
This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of semaglutide once-weekly vs. placebo on depressive symptoms in 116 patients with Major Depressive Disorder (MDD) and co-existing overweight or obesity. The treatment will be an add-on treatment to the patient's usual medication. The investigators hypothesize that adjunctive treatment with semaglutide, will lead to a significant improvement in mood compared to placebo in patients with MDD and overweight or obesity.
The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from start to follow-up after 26 weeks. The MDI measures the extent to which symptoms of depression have been present in the past two weeks.
Detailed description
This 26 week, randomized, double-blinded, placebo-controlled clinical trial investigate effects of semaglutide once-weekly vs. placebo on depressive symptoms in patients with unipolar disorder and comorbid obesity or overweight aged 18 years to 65 years. The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from week 0 to week 26.
Participants will be randomized to receive once-weekly injection of either semaglutide or placebo.
Patients will be treated for 26 weeks with an initial dose of semaglutide of 0.25 mg once weekly for four weeks, 0.50 mg once weekly for four weeks 1.0 mg for four weeks, 1.7 mg for four weeks and finally 2.4 mg for the remaining treatment period. Assessments will be conducted at weeks 0, 4, 8, 12, 16, 20, 24, and 26. Adherence and adverse events will be assessed during the entire treatment period. In addition, heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. The diagnosis of depression will be confirmed at baseline and depressive symptoms will be assessed with Hamilton Depression Rating Scale (HAM-D17) at baseline week 0, 12 and 26. MDI will be completed monthly. Participants will also complete questionnaires on physical activity, cognitive complaints, perceived stress, the reward system, Quality of life, alcohol use, and sleep quality at baseline and week 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide Injectable ProductWegovy once--weekly s.c titrated to max dose of 2.4 mg |
| Placebo | Placebo comparator | Drug: PlaceboSaline s.c. once-weekly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed oral and written consent.
- 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
- Hamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥14,
- Age 18 years to 65 years (both included)
- Body mass index (BMI) ≥27 kg/m2
Key exclusion criteria (14 listed)
- 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, on-going drug, or alcohol abuse
- Coercive measures
- Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus two months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device - IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
- Patients treated with corticosteroids or other hormone therapy (except oestrogens).
- Any active substance abuse or dependence (except for nicotine)
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 |
|---|---|---|
| Semaglutide Injectable ProductSemaglutide (Wegovy) once-weekly injection s.c | Drug | Semaglutide |
| PlaceboPlacebo (BD Posiflush) once-weekly injection s.c | Drug | Placebo |
Primary outcome
Change in depressive symptoms
Time frame: From baseline to 26 weeks of treatment
Change in depressive symptoms measured by the Major Depression Inventory (MDI; 12-item self-report mood questionnaire). The scale ranges from 0 to 50, with higher scores indicating worse outcome.
5 secondary outcomes
Glycaemic control parameters (blood sampling)
Time frame: From baseline to 26 weeks of treatment
Body weight
Time frame: From baseline to 26 weeks
Waist circumference
Time frame: From baseline to 26 weeks of treatment
Hamilton Depression Rating Scale, 17-items (HDRS-17) score
Time frame: From baseline to 26 weeks of treatment
Functioning assessment short test (FAST) score
Time frame: From baseline to 26 weeks of treatment
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 6 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be shared upon reasonable and relevant requests, such as for meta-analyses. All IPD will be anonymized or de-identified to protect participants' privacy and in accordance with applicable regulations, including the GDPR.
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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.
Christoffer Stanislaus, MD, ph.d.-student contact
Maj Vinberg, MD, PhD, DMSc principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
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 Semaglutide Injectable Product in people with Major Depressive Disorder, run by Nordsjaellands 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 6 inclusion and 14 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 6 Feb 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. Some participants in this study may receive a placebo. 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 Maj Vinberg, MD, DMSc (+ 45 38 64 32 27, maj.vinberg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (time frame: From baseline to 26 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.