2026-526685-25-00Not yet recruitingPhase 2
RECAP-D
The Role of Serotonin 4 Receptor Agonism in Regulating Mood and Cognition in Depression in women (RECAP-D)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2026
Brief summary (registry, in English)
The primary objective of this trial is to determine whether targeting the 5-HT4 receptor can enhance clinical response to antidepressant treatment and improve cognitive function in women with MDD. We aim to do this by determining 1) If adjunctive prucalopride intervention compared to placebo will result in lower levels of depressive symptoms after 8 weeks of sertraline treatment. 2)If adjunctive prucalopride intervention compared to placebo will result in better verbal memory performance after 8 weeks of sertraline treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 12 Jun 2026
- Start date
- 1 Aug 2026
- Lead sponsor
- Region Hovedstaden
- Diseases
- Depression
- EU CT number
- 2026-526685-25-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 106
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current schizophrenia diagnosis or psychosis/psychotic symptoms
- Menopause, perimenopause or use of hormonal replacement therapy
- For participants volunteering for PET and/or MR-scan program, contraindications for MRI (e.g. metal implants, claustrophobia or back problems)
- No use of antidepressant drugs within 2 months of inclusion or current use of other antidepressant treatment including psychotherapy
- Use of prescription drugs with known serotonergic effects within 2 months of inclusion
- More than one prior antidepressant drug treatment attempt in current depressive episode or known non-response to SSRI
Other illness
- Patients with well-controlled diabetes mellitus may be included in the study, but excluded from the central and peripheral insulin sensitivity tests.
- Imaging specific exclusion criteria: Allergy or contraindication to ingredients in the administered drugs or PET tracer
- Contraindication for use of prucalopride, e.g., presence of Ileus, Crohn disease or colitis ulcerosa or hereditary galactosemia
- Alcohol or substance use disorders
- Other psychiatric diagnoses which require independent treatment beyond SSRIs
- Traumatic brain injury or severe somatic disease including patients with decreased kidney function requiring dialysis
Other
- Pregnancy or breastfeeding or any plan to become pregnant within the next 3 months
- Insufficient Danish language skills to complete cognitive and psychometric testing
- For participants volunteering for PET and/or MR-scan program, participation in experiments with exposure to radioactivity (> 10 mSv) within the last year or significant occupational exposure to radioactivity
- Current use of erythromycin
- Contraindications for use of sertraline
- Acute suicidality
- Duration of depressive episode exceeding 2 years
Who the study is looking for
- Female biological sex
- Age 18-50 years
- Meets ICD-10 criteria for a primary moderate to severe unipolar depressive episode (F32–F33), not secondary to organic or other psychiatric disorders, with an indication for SSRI monotherapy.
Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.