Know Cancer

or
forgot password

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


Phase 4
20 Years
65 Years
Not Enrolling
Female
Breast Cancer, Depression, Anxiety

Thank you

Trial Information

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.


Inclusion Criteria:



- Age: 20-65 years;

- Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2
comprehensive clinical attending physicians, in line with clinical diagnosis of
breast cancer;

- A week after breast cancer surgery;

- With complaints and symptoms of depression or anxiety

- HAMD-17 ≥ 14 points or / and HAMA ≥ 14 points;

- Have some reading comprehension skills (could complete the self-rating scale
independently or with others' help);

- Informed consent

Exclusion Criteria:

- Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing
history;

- Use antidepressants, antipsychotics or accept any form of psychological treatment, or
participation in other clinical trials in the last month

- Patients with cardiovascular disease, liver and kidney dysfunction and other serious
diseases;

- Hearing, visual or understanding impairment;

- Severe depression, suicidal tendencies;

- Can not or will not comply with clinical treatment programs based on the physicians'
judgment

Exit criteria:

- Persons with poor compliance during the trial period;

- Persons whose depression increased during the trial period, has serious suicidal
tendencies and requires urgent intervention;

- Persons who are believed have other circumstances and should be suspended by
Physicians

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in Depression and Anxiety at 24 weeks, Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Scale (HAMA)

Outcome Description:

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%

Outcome Time Frame:

the 1st, 4th, 8th, 12th,16th and24th week

Safety Issue:

Yes

Principal Investigator

Jin C He, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Wenzhou Medical University

Authority:

United States: Food and Drug Administration

Study ID:

2009BAI77B06-3

NCT ID:

NCT01256008

Start Date:

December 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Depression
  • Anxiety
  • Breast Cancer Patients
  • Breast Cancer
  • Depression
  • Anxiety
  • Cognitive-Behavioral Therapy
  • Escitalopram(Lexapro)
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Depressive Disorder

Name

Location