2026-526314-90-00Not yet recruitingPhase 4
UNPRESCRIB-D
Unprescribing the Pill to Reassess Symptom and Cognitive Recovery in Depression (UNPRESCRIB-D)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Oct 2026
Brief summary (registry, in English)
The primary objectives are to determine if COC discontinuation (COCd) compared with COC continuation (COCc) affects (i) antidepressant treatment outcome and (ii) verbal memory performance at week 8 under concomitant pharmacological antidepressant treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 27 Mar 2026
- Start date
- 1 Jun 2026
- Lead sponsor
- Region Hovedstaden
- Diseases
- Depression
- EU CT number
- 2026-526314-90-00
What you commit to
- Study type: Interventional · Phase 4
- 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
- Menopause, perimenopause or use of hormonal replacement therapy
- Additional exclusion criteria for participants volunteering for MRI and MRI/PET scan program: Contraindications for MRI (e.g. metal implants or claustrophobia)
- Additional exclusion criteria for participants volunteering for MRI and MRI/PET scan program: Use of prescription drugs with known serotonergic effects within 2 months of inclusion, including sertraline and other antidepressants
- Prior or current schizophrenia diagnosis or psychosis/psychotic symptoms
- Other antidepressant drug treatment attempt in current depressive episode
Other illness
- Severe somatic disease or traumatic brain injury
- Moderate to severe gynecological conditions in which COCs are recommended as standard treatment, including endometriosis, severe dysmenorrhea, severe acne, menorrhagia associated with anemia, and polycystic ovary syndrome.
- Alcohol and substance use disorders
- Other psychiatric disorder requiring other treatments than SSRI
Other
- Acute suicidality
- Duration of depressive episode exceeding 2 years
- Pregnancy or breastfeeding or any plan to become pregnant within the next 3 months
- Insufficient Danish language skills to complete cognitive and psychometric testing
- Contraindication for use of Femicept
- Additional exclusion criteria for participants volunteering for MRI/PET scan program: Participation in experiments with exposure to radioactivity (> 10 mSv) within the last year of significant occupational exposure to radioactivity (only participants volunteering for the MRI/PET scan program)
- Contraindication for use of sertraline and duloxetine
- Other current antidepressant treatment, including psychotherapy, than sertraline
- Use of sertraline for more than 1 month at inclusion
- Known non-responder to SSRI
Who the study is looking for
- Female biological sex
- Age 18-39 years
- Current user of combined oral contraception, which was started at least one month prior to inclusion
- Fulfillment of ICD-10 for primary moderate to severe unipolar depressive episode (i.e., not secondary to organic or other psychiatric disorder), for which treatment with SSRI monotherapy is clinically indicated.
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 Oe | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.