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Not yet taking people in DenmarkPhase 2

Prucalopride added to sertraline for depression in women

Tests prucalopride alongside sertraline for mood and memory in women with depression.

Key facts

Who runs it
Region Hovedstaden
Where
Copenhagen, DenmarkSee the site
Registry title
RECAP-D
Status
Not yet recruiting
Phase
Phase 2
People taking part
106 people, planned
Started
1 Aug 2026
Expected to end
31 Aug 2036
Type of study
Interventional
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18-50 with a moderate to severe depressive episode who need an SSRI antidepressant. It tests whether adding prucalopride to sertraline helps mood and memory.

Age
18-50 years
Sex
Women only
Disease stage
A first-time or recurring depressive episode (unipolar), moderate to severe, not caused by another illness. The episode has lasted no more than 2 years.
Earlier treatment
No antidepressant drugs within 2 months before joining and no other antidepressant treatment now, including psychotherapy. No more than one earlier antidepressant attempt in this episode. No known non-response to an SSRI.

Main reasons for not taking part

  • Schizophrenia or psychosis, now or in the past
  • Pregnancy, breastfeeding, or a plan to become pregnant within the next 3 months
  • Menopause, perimenopause or hormone replacement therapy
  • Alcohol or substance use disorder, or acute suicidal thoughts
  • Cannot take prucalopride or sertraline for medical reasons

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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 Denmark

  • RigshospitaletCopenhagen, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
The Role of Serotonin 4 Receptor Agonism in Regulating Mood and Cognition in Depression in women (RECAP-D)
Plain-language title
Prucalopride added to sertraline for depression in womenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2026-526685-25-00, who can take part
Record updated
30 October 2026