2026-526314-90-00招募中4 期
Unprescribing the Pill to Reassess Symptom and Cognitive Recovery in Depression (UNPRESCRIB-D)
Region Hovedstaden1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The mean Hamilton Depressive Rating Scale 6-item (HRDS-6) score
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The mean Hamilton Depressive Rating Scale 6-item (HRDS-6) score
The mean Hamilton Depressive Rating Scale 6-item (HRDS-6) score
The mean total Verbal Affective Memory Task 24 (VAMT-24) recall score calculated as the average score across the immediate (0-24), short- (0-24), and long-term (0-24) recall
The mean total Verbal Affective Memory Task 24 (VAMT-24) recall score calculated as the average score across the immediate (0-24), short- (0-24), and long-term (0-24) recall
次要结局
- Antidepressant treatment titration rank as defined in the protocol
- Mean HRDS-6 score
- The mean total Rey- Auditory Verbal Learning Test (RAVLT) recall score calculated as the average score across the immediate (0-15), short- (0-15), and long-term (0-15) recall
- Domain-specific end point 1: Mean striatal 5-HT4R non-displaceable binding potential (BPND) as measured by positron emission tomography
- Domain-specific end point 2a: Mean hypothalamic blood flow response to oral glucose as a proxy for brain insulin sensitivity
- Domain-specific end point 2b: Mean hypothalamic blood-oxygen-level-dependent response to oral glucose
- Domain-specific end point 2c: Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) as a measure for peripheral insulin sensitivity
- Domain-specific end point 3: Mean cortisol awakening response
- Domain-specific end point 4a: Mean extra-neurite mean diffusivity as a proxy for brain inflammation
- Domain-specific end point 4b: Mean hcCRP as a measure of peripheral inflammation
- Domain-specific end point 4c: kynurenic acid/quinolinic acid ratio (neuroprotective index)
- Domain-specific end point 5: Mean hippocampal activation as measured by functional magnetic resonance imaging (fMRI) during a memory encoding paradigm
- Domain-specific end point 6a: Mean Element of Desire score
- Domain-specific end point 6b: Mean ventral striatal activation as measured by fMRI during a monetary reward paradigm
- Domain-specific end point 7: Mean General Anxiety Disorder-7 score
- Domain-specific end point 8: Mean resting state functional connectivity as measured with resting state fMRI
- Domain-specific end point 9: Mean hippocampal gray matter volume as measured with magnetic resonance imaging (MRI)
- Domain-specific end point 10a: Gut microbiome composition
- Domain-specific end point 10b: Mean gut microbiome-derived metabolites
- Domain-specific end point 11: Mean Pittsburgh Sleep Quality Index score
- Domain-specific end point 12a: Mean Major Depression Inventory (MDI) score
- Domain-specific end point 12b: Mean HRDS-6 score
- Domain-specific end point 12c: Treatment titration rank (defined in the protocol)
- Domain-specific end point 12d: Time to remission
- Domain-specific end point 12e: Time to hospitalization, suicide, suicide attempt, or treatment switches/add-on
研究者
Søren Vinther Larsen
Scientific
Region Hovedstaden
研究点 (1)
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