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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Depression
Anxiety
Behavioral: CBT and clinical management
Drug: Escitalopram
Behavioral: Clinical Management
Drug: Sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • 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%



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 392
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: stage 1 clinical management
The group will receive clinical management treatment only each session.
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
Experimental: stage1 CBT and clinical management
The experimental group will receive CBT and clinical management treatment simultaneously each session.
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
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.
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
Placebo Comparator: stage 2 Sugar pill
The controlled group will use the same dose of placebo which has similar appearance, color, odor to Lexapro.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256008

Contacts
Contact: Guang Y Mao, PhD +86-577-86689848 maogy.net@gmail.com
Contact: Lei L Zeng, Bachelor +86-577-88069798 imzlei@yahoo.com.cn

Locations
China, Zhejiang
Wenzhou Medical College Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Lei L Zeng, Bachelor    +86-577-88069798    imzlei@yahoo.com.cn   
Sponsors and Collaborators
Wenzhou Medical University
Anhui Medical University
Central South University
Harbin Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Wuhan University
Investigators
Study Chair: Jin C He, MD Wenzhou Medical University
  More Information

No publications provided

Responsible Party: Jincai He/Prof., Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01256008     History of Changes
Other Study ID Numbers: 2009BAI77B06-3
Study First Received: December 6, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration
China: Ethics Committee

Keywords provided by Wenzhou Medical University:
Breast Cancer Patients
Breast Cancer
Depression
Anxiety
Cognitive-Behavioral Therapy
Escitalopram(Lexapro)

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Behavioral Symptoms
Breast Diseases
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Site
Skin Diseases
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on November 23, 2014