NCT01239888Unknown1 期
Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression
The Alfred1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and tibolone ad-on can induce a response to antidepressants in patients with treatment resistant depression.
详细描述
We are examining the efficacy and safety of oxytocin or oxytocin and tibolone with an antidepressant (SSRIs) in treatment resistant depression in a double-blind randomized clinical trial.
A secondary objective is the evaluation of neurobiological factors contributing to drug efficacy in treatment resistant depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years
- •Current DSM-IV diagnosis of Major Depression
- •Comorbid anxiety disorders secondary to depression will be included
- •Past history of at least 2 failed treatment responses (including SSRIs) at the highest tolerated dose for at least 4-6 weeks
- •A MADRS score >20 at randomization
- •Women on a stable dose of an SSRI (sertraline, citalopram, escitalopram, paroxetine, fluoxetine or fluvoxamine) for at least 4-6 weeks.
- •A negative pregnancy test at screening
- •A clinically acceptable Pap smear within the past 2 years
- •Must be able to use intranasal spray and swallow tablets
- •Patients may take up to 2 sleep medications permitted at a dose considered reasonable by the investigating team. Limited adjustments in sleep medication are acceptable. Patients will be asked to notify the researchers of any changes to their sleep medication.
排除标准
- •Any previous history of adverse side-effects to escitalopram (or other SSRI)
- •Use of oral contraceptives (or any hormonal method of contraception) for the duration of the study
- •DSM-IV defined substance dependence, history of bipolar disorder, schizoaffective disorder or schizophrenia
- •Significant unstable medical illness including epilepsy, diabetes or cardiac related, renal or liver disease, hormone dependent cancer or pregnancy
- •A BMI<18 or > 34kg/m2
- •Planning for pregnancy
- •Renal disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at any time before study entry or thrombo-phlebitis within the last 5 years, or any other major illness that has occurred within the last 6 months.
- •An undiagnosed genital bleeding
- •Moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia ( will exclude women with clinically meaningful androgen excess)
- •Active malignancy, or treatment for malignancy in the preceding 6 months (excluding non-melanotic skin cancer)
- •Alcohol consumption in excess of 3 standard drinks per day
- •Lactose intolerance
- •An abnormal thyroid stimulating hormone (TSH) value at screening confirmed by a Free T4 outside the normal laboratory range (patients with an abnormal TSH, normal Free T4 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study).
- •A history of allergic reactions to androgens (oral or patch)
- •Chronic medications: aspirin and warfarin
研究组 & 干预措施
Oxytocin
Active Comparator
干预措施: Oxytocin (Drug)
Oxytocin and Tibolone
Active Comparator
干预措施: Oxytocin and Tibolone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
次要结局
- Change from baseline in Hamilton Rating Scale for Depression (HAM-D)(Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks)
- Change from baseline in Beck Depression Inventory II (BDI-II)(Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks)
- Change from baseline in State Trait Anxiety Inventory (STAI)(Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks)
- Adverse Symptom Check List(baseline, week 2, week 4, week 8)
- Perceived stress scale(baseline, week 2, week 4, week 8)
- Pittsburgh sleep quality index(baseline, week 2, week 4, week 8)
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(baseline, week 2, week 4, week 8)
研究者
Charlotte Keating
Research Fellow
The Alfred
研究点 (1)
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