Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
研究概览
简要总结
60 patients with chronic major depressive disorder according to DSM-IV will be included into the study. Patients will be randomized to receive an open treatment either with CBASP, a psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28 weeks.
详细描述
The psychotherapeutic treatment with CBASP will be conducted in 2 weekly sessions for the first 4 weeks, one per week thereafter until week 9, followed by one session every 2 weeks for 20 more weeks. The starting dose for Escitalopram will be 10 mg/d for one week and will be increased to 20 mg/d after one week. The dosage can be reduced to 10 mg/d after day 7 to improve tolerance. Th MADRS-scale is the primary outcome measure; ratings will be performed by a blinded rater. If there is no improvement (reduction of less than 20% of the MADRS), patients will be crossed over in terms of adding the other treatment at week 8. Study patients will be asked to participate in fMRI, genetic and pharmacological substudies.
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
- None
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
- •Chronic MDD according to DSM-IV (modification: depressive symptomatology for at least one year), or recurrent MDE (third or greater episode with the immediately preceding episode being no more than 2.5 years before the onset of the present episode)
- •Age 18-65
- •Score of at least 18 on the Montgomery-Asberg-Rating Scale for Depression (MADRS)
排除标准
- •Acute risk for suicide
- •History of psychotic symptoms, bipolar disorder or dementia
- •Severe substance-related abuse or dependence disorder
- •Schizotypal, antisocial or borderline personality disorder
- •Serious medical condition
- •Severe cognitive impairment
- •Absence of a response to previous adequate trial of the study medication/CBASP
- •Hypersensitivity to Escitalopram
- •Treatment with a MAO-inhibitor within 1 week before the initiation of study treatment
研究组 & 干预措施
CBASP
CBASP psychotherapy
干预措施: CBASP psychotherapy (Other)
Escitalopram
Escitalopram pharmacotherapy and clinical management
干预措施: Escitalopram (Drug)
结局指标
主要结局
Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
时间窗: 8 weeks
次要结局
- Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization(28 weeks after ranomization)