Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
研究概览
简要总结
To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive).
- •Patients with a "moderate-severe" level of emotional distress who meet the diagnostic criteria for major depression for at least two weeks or adjustment disorder with depressive mood for at least two months, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (DSM-V), during the twelve months following the diagnose of breast cancer.
- •Informed Consent Form Signature
排除标准
- •Women who are pregnant or breastfeeding.
- •Suicide risk.
- •Metastatic brain disease.
- •Personal History of oncological disease.
- •Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).
- •Personal History of organic brain disorder, substance abuse/dependence.
- •Personal History of psychotic disorder, bipolar disorder and/or mental retardation.
- •Contraindications of citalopram treatment.
- •Taking antidepressants after the breast cancer diagnosis.
- •Psychotherapy treatment after breast cancer diagnosis .
研究组 & 干预措施
Citalopram 20-40 mg
Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.
干预措施: Citalopram (Drug)
Psychotherapy
Participants received one psychotherapy session weekly for 12 weeks.
干预措施: Psychotherapy (Behavioral)
结局指标
主要结局
Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
时间窗: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
The BDI is a validated, self-reported instrument assessing the severity of depression. Scoring range 0-9 indicates minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
次要结局
- Cancer treatment received.(Baseline.)
- Number and severity of secondary side effects related to the consumption of pharmacological treatment with citalopram according to the side effects rating scale Udvalg für Kliniske Undersogelser (UKU).(At week 3, 6, 9 and 12.)
- Change from Baseline in quality of life on the European Quality of Life Scale Five Dimensions and Three Levels (EQ-5D-3L) at week 12.(Baseline and week 12.)
- Change from Baseline in social-labor adaptation measured by number of days off work at week 12.(Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).)
- Marital status.(Baseline.)
- Breast cancer stage.(Baseline.)
- Age of patients.(Baseline.)
- Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).(fMRI at baseline.)
- Cost-effectiveness ratio differences between pharmacological treatment with citalopram and psychological treatment in patients in our environment with breast cancer (BC) and major depression (MD).(At week 12.)
- Change from baseline in emotional processing on the Dot-Probe Task (DPT).(DPT at baseline and week 12.)
研究者
Cinto Segalàs Cosi, MD
Psychiatrist at the Bellvitge University Hospital. Researcher at the Bellvitge Biomedical Research Institute (IDIBELL). Associate professor at the Clinical Sciences Department of the Barcelona University (UB).
Hospital Universitari de Bellvitge