Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders: a Pilot Study (CRY-MOOD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Primary outcomes determined by the proportion of non-responders (< 30 % improvement on the MADRS) after 2 weeks of treatment and the proportion of non-responders randomized patients who completed the study.
研究概览
简要总结
Major depressive disorder is a common mental disorder and the leading cause of disability worldwide. According to the Canadian Network for Mood and Anxiety Treatment, early improvement following an antidepressant treatment is correlated with response and remission. Escalation of an antidepressant dose after 2 weeks, as opposed to 4 to 8 weeks, is proposed to favor early improvement. However, this has never been tested systematically in a controlled study involving major depressive disorder patients that are non-responders to their antidepressant treatment.
详细描述
The investigators sought to assess whether it is feasible to perform a prospective randomized controlled double-blind feasibility study with a 2 week run-in period and 3 parallel groups randomized controlled study using citalopram. Citalopram has physicochemical properties compatible with over-encapsulation and a has a simple titration that allows the study of early dose increase.. It is among the most prescribed antidepressant in the province of Quebec and at the Hospital Maisonneuve-Rosemont - University family medicine group (U-FMG).
Since establishment of a randomized controlled trial is complex and expensive, a feasibility design is appropriate to identify all the obstacles and to minimize sources of possible bias (recruitment, follow up, resources).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Over-encapsulation was performed to maintain blind.
Every participant will have the same step (visits, follow up, questionnaire and interview).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand french or english
- •Primary diagnostic of major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders criteria (5th edition)
- •Prescription of citalopram
- •Citalopram started less than 4 days ago
- •Able to receive informed consent
- •Not participating to another study
排除标准
- •Pregnancy or breastfeeding
- •Unable to participate to follow-up
- •Hypersensitivity to citalopram or any component of the formulation
- •Known QT interval prolongation or congenital long QT syndrome
- •Hepatic impairment (Child Pugh A, B or C)
- •Renal impairment (Clcr < 30 ml/min)
- •Known cytochrome P450 2C19 poor metabolizers
- •History of non-response to citalopram
- •Head trauma or severe cognitive impairment
- •Substance-related and addictive disorders controlled less than 3 months or uncontrolled
- •Schizophrenia or psychotic disorder
- •Mixed depression
- •History of manic/hypomanic episodes
- •Use of prohibited drugs : monoamine oxidase inhibitors, cytochrome P450 2C19 inhibitors, drugs at risk of causing prolongation of the QT interval, cimetidine, pimozide and antidepressors taken for another psychiatric condition.
研究组 & 干预措施
Citalopram increase (group A)
At the end of the preparation phase, non-responders will be randomized to receive a pill of citalopram 20 mg and a capsule of citalopram 20 mg for a length of 14 days. The total dose of citalopram will be 40 mg once daily.
Follow up will last 8 weeks in total.
干预措施: Citalopram 20mg or 40 mg (phase 2) (Drug)
Placebo (group B)
At the end of the preparation phase, non-responders will be randomized to receive a pill of citalopram 20 mg and a capsule of placebo (a capsule without medication) for a length of 14 days. The total dose of citalopram will be 20 mg once daily.
Follow up will last 8 weeks in total.
干预措施: Citalopram 20mg or 40 mg (phase 2) (Drug)
结局指标
主要结局
Primary outcomes determined by the proportion of non-responders (< 30 % improvement on the MADRS) after 2 weeks of treatment and the proportion of non-responders randomized patients who completed the study.
时间窗: 8 weeks
The efficacy of treatment was assessed by the Montgomery and Asberg Depression Rating Scale (MADRS).Threshold for non-responders : \< 30 % improvement on the MADRS between T2 and T0. This scale was completed by a trained assessor and measures the severity of depressive episodes in patients with mood disorders. The scale is in french and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. Criteria for success of the randomization and completion of the study : * Sample size target : 24 non-responders randomized patients * Proportion of non-responders after 2 weeks of treatment (T2) : ≥ 0.45 (number of non-responders after 2 weeks of treatment divided by the number of enrolled patients). * Proportion of non-responders randomized patients who completed the full course of treatment (8 weeks) : ≥ 0.65 (number of non-responders randomized patients who completed the study divided by the total number of enrolled patients).
次要结局
- Proportion of eligible subjects(8 weeks)
- Recruitment rate(8 weeks)
- Retention rate(8 weeks)
- Adherence rate to treatment(8 weeks)
- Unblinding rate(8 weeks)
- Length of interviews(8 weeks)
- Side effects reported to the assessors and measured by the Frequency, Intensity, and Burden of Side Effect Rating (FIBSER).(8 weeks)
- Response curves for all patients according to the results from the MADRS.(8 weeks)
- Correlation between the results of Patient Health Questionnaire-9 (PHQ-9) and the MADRS at each follow-up (T2, T4, T6 and T8).(8 weeks)
研究者
Marie-Claude Lefebvre
Principal investigator
Ciusss de L'Est de l'Île de Montréal