Intervention Study of Depression in Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Wenzhou Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Anhui Medical University
Central South University
Harbin Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Wuhan University
Information provided by:
Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01256008
First received: December 6, 2010
Last updated: December 7, 2010
Last verified: November 2010

December 6, 2010
December 7, 2010
December 2010
June 2012   (final data collection date for primary outcome measure)
Change from Baseline in Depression and Anxiety at 24 weeks, Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Scale (HAMA) [ Time Frame: the 1st, 4th, 8th, 12th,16th and24th week ] [ Designated as safety issue: Yes ]

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%

Same as current
Complete list of historical versions of study NCT01256008 on ClinicalTrials.gov Archive Site
Hospital Anxiety and Depression Scale (HAD), Quality of Life (FACT-B), well-being index, pain score, Athens Insomnia Scale [ Time Frame: the 4th and the 12th week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intervention Study of Depression in Breast Cancer Patients
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

The purpose of this study is to evaluate the efficacy of sequential therapy which combines cognitive-behavioral therapy with antidepressants on depression and anxiety 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
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Breast Cancer
  • Depression
  • Anxiety
  • Behavioral: CBT and clinical management
    The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.
    Other Names:
    • cognitive-behavioral intervention
    • psychological intervention
  • Drug: Escitalopram

    After the first stage of psychological treatment, if there is no significant improvement in depressive symptoms, with or without anxiety symptoms, with more than 2 attending practitioner psychiatrists or psychological doctors' diagnosis, consistent with DSM-Ⅳ diagnostic criteria for depressive episode, HAMD-17≥14 points, duration ≥2weeks.

    Groups and drug selection: the subjects will be randomly assigned to experimental group or controlled group.Lexapro group: (Xian-Janssen Pharmaceutical production): 2 tablets per day, early in the morning, for 12 weeks, could start with 1 tablet in the first 7 days; The controlled group: using the same dose of placebo which has similar appearance, color, odor to Lexapro.

    Other Names:
    • Lexapro
    • Drug Therapy
  • Behavioral: Clinical Management

    Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.

    Following are major elements:

    Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.

    Other Name: Placebo of Cognitive-Behavioral therapy
  • Drug: Sugar pill

    After the first stage of psychological treatment, if the subjects fulfill the criteria, then they will be randomly assigned to experimental group or controlled group.

    In the controlled group, the subjects will take a placebo which has similar appearance, color, odor to Lexapro: 2 tablets per day, early in the morning, for 12 weeks, could start with 1 tablet in the first 7 days.

    Other Name: Placebo
  • Placebo Comparator: stage 1 clinical management
    The group will receive clinical management treatment only each session.
    Intervention: Behavioral: Clinical Management
  • Experimental: stage1 CBT and clinical management
    The experimental group will receive CBT and clinical management treatment simultaneously each session.
    Intervention: Behavioral: CBT and clinical management
  • Experimental: stage2 drug intervention
    The experimental group will take Lexapro (Xian-Janssen Pharmaceutical production): 2 tablet per day, early in the morning, for 12 weeks, could start with 1 tablet in the first 7 days.
    Intervention: Drug: Escitalopram
  • Placebo Comparator: stage 2 Sugar pill
    The controlled group will use the same dose of placebo which has similar appearance, color, odor to Lexapro.
    Intervention: Drug: Sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
392
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
20 Years to 65 Years
No
Contact: Guang Y Mao, PhD +86-577-86689848 maogy.net@gmail.com
Contact: Lei L Zeng, Bachelor +86-577-88069798 imzlei@yahoo.com.cn
China
 
NCT01256008
2009BAI77B06-3
Yes
Jincai He/Prof., Wenzhou Medical College
Wenzhou Medical University
  • Anhui Medical University
  • Central South University
  • Harbin Medical University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Wuhan University
Study Chair: Jin C He, MD Wenzhou Medical University
Wenzhou Medical University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP