Vortioxetine for Menopausal Depression and Associated Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
研究概览
简要总结
The broad goal of this study was to examine the efficacy and tolerability of vortioxetine (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women around the menopausal transition. We hypothesized that an eight-week treatment with vortioxetine would promote a significant improvement of depression symptoms and other menopause-related physical symptoms.
详细描述
Forty-seven peri- and postmenopausal women were enrolled in this open-label study. This was an 8-week intervention using open-label vortioxetine with flexible dose between 5-20 mg, dependent on participant response and tolerability. In addition to assessment of depressive symptoms, improvement of menopause-related physical and emotional symptoms that occur with MDD, including vasomotor symptoms, cognition, fatigue, anxiety, sleep complaints, and quality of life, were also examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years of the last menstrual period if not surgically postmenopausal), including:
- •Perimenopausal women who have experienced changes in menstrual cycle frequency or duration, and/or physical symptoms indicative of menopausal transition, as determined by clinician
- •Women who are using the Mirena Intrauterine Device (IUD), with Follicle-stimulating hormone (FSH) level > 20 milli-International unit/ml (mIU/mL)
- •Women meeting Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for major depression (assessed by the Mini International Neuropsychiatric Interview - M.I.N.I.)
- •MADRS scores of at least 20 at baseline visit
- •Women with significant menopause-related physical symptoms, indicated by any of the following criteria:
- •Greene Climacteric Scale total scores > 20;
- •Greene Climacteric Scale sub-score for vasomotor symptoms >3;
- •14 or more bothersome hot flashes per week (self-reported).
- •Signed informed consent.
排除标准
- •Pregnancy (determined by urine pregnancy test), intending pregnancy, or breast feeding.
- •Women whose primary diagnosis is Panic Disorder, Obsessive Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), Seasonal Affective Disorder (SAD), or any other Axis I pathology active within 6 months prior to screening visit (except for specific phobias). Anxiety disorders are allowable if secondary to MDD as the primary diagnosis.
- •History of or current mania/hypomania, psychosis, or bipolar disorder
- •Regular treatment with an Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Norepinephrine Reuptake Inhibitors (SNRI) within 2 months prior to screening visit
- •Serious suicidal ideation or intent
- •Women who have used psychoactive or centrally acting medications within 2 weeks prior to study screening
- •Women who have received hormonal intervention within 1 month prior to study entry
- •Known hypersensitivity to vortioxetine or any of the inactive ingredients
- •Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 21 days of discontinuation of study drug
- •Treatment with linezolid or intravenous methylene blue
- •Patients with severe hepatic impairment
- •Uncontrolled hypertension (>160/90 mmHg)
- •Resting heart rate >110/minute
- •Any current severe or unstable medical illness
- •Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
- •Drug or alcohol abuse in the past 1 year
- •Use of any disallowed medications (specified in the Excluded Concomitant Medication section below)
- •Concurrent enrollment in another clinical trial
- •Excluded Concomitant Medications:
- •Selective estrogen-receptor modulators (SERMs)
- •Hormone replacement therapy
- •Hormonal contraceptives, excluding Mirena IUD
- •Natural menopause supplements
- •Episodic sleep medications (chronic, regular, stable-dose benzodiazepines are allowed)
- •Antidepressants
- •Phytoestrogens
- •Soy-based medications
- •Anorectics, appetite depressants
研究组 & 干预措施
open-label vortioxetine
flexible-dose vortioxetine of 5-20 mg depending on tolerability
干预措施: vortioxetine (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
时间窗: Baseline and Week 8 (Visit 5)
The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.
次要结局
- Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
- Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)(Baseline and Week 8 (Visit 5))
研究者
Marlene P. Freeman, MD
Associate Director, Center for Women's Mental Health
Massachusetts General Hospital