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Not yet taking people in DenmarkPhase 4

Stopping the combined pill during depression treatment to test mood and memory

Tests stopping versus continuing the combined pill in adults with depression.

Key facts

Who runs it
Region Hovedstaden
Where
Copenhagen Oe, DenmarkSee the site
Registry title
UNPRESCRIB-D
Status
Not yet recruiting
Phase
Phase 4
People taking part
106 people, planned
Started
1 Jun 2026
Expected to end
31 Dec 2035
Type of study
Interventional
Record updated
2 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 18-39 with a moderate to severe first-line depressive episode who use combined oral contraception and need an SSRI antidepressant.

Age
18-39 years (the record also lists a maximum age of 64 years).
Sex
Women only.
Disease stage
Moderate to severe unipolar depressive episode (ICD-10), not caused by another medical or psychiatric disorder, where SSRI treatment alone is clinically indicated. The episode must not have lasted more than 2 years.
Earlier treatment
Must be taking combined oral contraception, started at least one month before joining. Must not have used sertraline for more than 1 month, tried another antidepressant drug in this episode, or be a known non-responder to SSRIs.

Main reasons for not taking part

  • Acute suicidality
  • Pregnancy, breastfeeding, or plans to become pregnant within 3 months
  • Schizophrenia, psychosis, or alcohol or substance use disorder
  • Severe physical illness or traumatic brain injury
  • Gynaecological conditions where the pill is the standard treatment, such as endometriosis or polycystic ovary syndrome

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

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 Oe, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

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.

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
Unprescribing the Pill to Reassess Symptom and Cognitive Recovery in Depression (UNPRESCRIB-D)
Plain-language title
Stopping the combined pill during depression treatment to test mood and memoryGenerated 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 2026-526314-90-00, who can take part
Record updated
2 October 2026