Early Identification and Early Warning of Psychological Problems in Breast Cancer Patients, and Intervention Study Using Cognitive Behavioral Therapy and Escitalopram on Depression in Breast Cancer Patients
Comprehensive intervention on depression and anxiety in breast cancer patients is a 24-week,
multicenter, randomized, blinded controlled clinical study, which uses cognitive-behavioral
therapy and antidepressants sequentially. This study tries to evaluate the efficacy of
sequential therapy on breast cancer patients' depression and its improvement on breast
cancer patients' life quality, pain and sleeping.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Change from Baseline in Depression and Anxiety at 24 weeks, Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Scale (HAMA)
Evaluation Criteria: Clinical recovery: After treatment, HAMD-17≤7 points and HAMA ≤7 points, the symptoms disappeared; Markedly: after treatment, total reduction rate of HAMD-17 or HAMA ≥ 75%, symptoms improved significantly; Effective: After treatment, compared to baseline, total reduction rate of HAMD-17 or HAMA≥50%, symptoms improved; Invalid: After treatment, total reduction rate of HAMD-17 or HAMA<50%, no improvement of symptoms. Note: Total reduction rate = [(pre-treatment score - post-treatment score) / baseline score] × 100%
the 1st, 4th, 8th, 12th,16th and24th week
Yes
Jin C He, MD
Study Chair
Wenzhou Medical University
United States: Food and Drug Administration
2009BAI77B06-3
NCT01256008
December 2010
December 2012
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