BridgeMD
UNPRESCRIB-D
EU CTIS ID: 2026-526314-90-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Acute suicidality
- Duration of depressive episode exceeding 2 years
- Severe somatic disease or traumatic brain injury
- Pregnancy or breastfeeding or any plan to become pregnant within the next 3 months
- Menopause, perimenopause or use of hormonal replacement therapy
- Insufficient Danish language skills to complete cognitive and psychometric testing
See the full eligibility criteria
- 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.
- Acute suicidality
- Duration of depressive episode exceeding 2 years
- Severe somatic disease or traumatic brain injury
- Pregnancy or breastfeeding or any plan to become pregnant within the next 3 months
- Menopause, perimenopause or use of hormonal replacement therapy
- Insufficient Danish language skills to complete cognitive and psychometric testing
- Contraindication for use of Femicept
- 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.
- 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/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)
- 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
- Alcohol and substance use disorders
- Other psychiatric disorder requiring other treatments than SSRI
- 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
- Other antidepressant drug treatment attempt in current depressive episode
- Known non-responder to SSRI
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.