RECAP-D
Key facts
- Where
- Copenhagen, DániaSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Dánia
- RigshospitaletCopenhagen, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2026-526685-25-00
- Record updated
- 2026. október 30.
- Original description
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.Read full original descriptionShow less
The Role of Serotonin 4 Receptor Agonism in Regulating Mood and Cognition in Depression in women (RECAP-D)
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.
Inclusion: 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.
Exclusion: 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; 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; 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.