UNPRESCRIB-D
Key facts
- Where
- Copenhagen Oe, DániaSee the site
- Phase
- 4. 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 Oe, 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 2026-526314-90-00
- Record updated
- 2026. október 2.
- Original description
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.Read full original descriptionShow less
Unprescribing the Pill to Reassess Symptom and Cognitive Recovery in Depression (UNPRESCRIB-D)
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.
Inclusion: 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.
Exclusion: 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; 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; 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.