search
Back to results

Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression (CAMAD)

Primary Purpose

Breast Cancer, Major Depressive Episode

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Citalopram
Psychotherapy
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Major Depressive Episode, Antidepressant Efficacy, Psychotherapy, Citalopram

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 .

Sites / Locations

  • Catalan Institute of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Citalopram 20-40 mg

Psychotherapy

Arm Description

Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.

Participants received one psychotherapy session weekly for 12 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
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.

Secondary Outcome Measures

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.
The EQ-5D-3L is a standardized measure of health-related quality of life. The EQ-5D descriptive system comprises five dimensions with three levels of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.
Change from Baseline in social-labor adaptation measured by number of days off work at week 12.
Number of days off work.
Age of patients.
Measured in years.
Marital status.
Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.
Cancer treatment received.
Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.
Breast cancer stage.
Breast cancer stage is expressed as a number on a scale from 0 to IV, where 0 describes non-invasive cancers that remain within their original location, and IV describes invasive cancers that have spread outside the breast to other parts of the body. This clinical information will be collected from the medical record.
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).
fMRI is a specialized form of magnetic resonance imaging used to examine regional brain activity, allowing the identification of the brain areas allegedly underpinning psychological processes. fMRI uses a specific imaging sequence (echo planar imaging) to measure small changes in blood oxygenation by assessing the so-called blood oxygenation level dependent (BOLD) signal over time, which is linked to regional neuronal function.
Change from baseline in emotional processing on the Dot-Probe Task (DPT).
The DPT is a validated task to assess emotional processing by measuring reaction time to two types of stimuli (emotional face vs. neutral face), each one displayed on a different side of the screen. A faster reaction to emotional stimuli than to neutral ones indicates a bias of attention towards the emotional face and reflects dysfunction on emotional processing.
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).
Analyze the cost of several variables, including both treatments (pharmacological and psychological), use of infrastructures and travel costs (only the first inclusion visit will be in person, the subsequent follow-up will be online).
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).
The UKU side effects scale is designed to evaluate the secondary effects derived from the consumption of psychotropic drugs. The UKU scale comprises a total of 54 items that describe 54 side effects. Each item takes a value from 0 to 3 (0, no or doubtful present; 1, mild; 2, moderate; 3, severe).

Full Information

First Posted
July 27, 2021
Last Updated
June 29, 2022
Sponsor
Hospital Universitari de Bellvitge
Collaborators
Institut Català d'Oncologia
search

1. Study Identification

Unique Protocol Identification Number
NCT05063604
Brief Title
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
Acronym
CAMAD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
June 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
Institut Català d'Oncologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Major Depressive Episode
Keywords
Breast Cancer, Major Depressive Episode, Antidepressant Efficacy, Psychotherapy, Citalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citalopram 20-40 mg
Arm Type
Experimental
Arm Description
Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.
Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Participants received one psychotherapy session weekly for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Prisdal
Intervention Description
20 mg tablet one or twice daily for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
One session weekly for 12 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
Description
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.
Time Frame
Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Secondary Outcome Measure Information:
Title
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.
Description
The EQ-5D-3L is a standardized measure of health-related quality of life. The EQ-5D descriptive system comprises five dimensions with three levels of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.
Time Frame
Baseline and week 12.
Title
Change from Baseline in social-labor adaptation measured by number of days off work at week 12.
Description
Number of days off work.
Time Frame
Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Title
Age of patients.
Description
Measured in years.
Time Frame
Baseline.
Title
Marital status.
Description
Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.
Time Frame
Baseline.
Title
Cancer treatment received.
Description
Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.
Time Frame
Baseline.
Title
Breast cancer stage.
Description
Breast cancer stage is expressed as a number on a scale from 0 to IV, where 0 describes non-invasive cancers that remain within their original location, and IV describes invasive cancers that have spread outside the breast to other parts of the body. This clinical information will be collected from the medical record.
Time Frame
Baseline.
Title
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).
Description
fMRI is a specialized form of magnetic resonance imaging used to examine regional brain activity, allowing the identification of the brain areas allegedly underpinning psychological processes. fMRI uses a specific imaging sequence (echo planar imaging) to measure small changes in blood oxygenation by assessing the so-called blood oxygenation level dependent (BOLD) signal over time, which is linked to regional neuronal function.
Time Frame
fMRI at baseline.
Title
Change from baseline in emotional processing on the Dot-Probe Task (DPT).
Description
The DPT is a validated task to assess emotional processing by measuring reaction time to two types of stimuli (emotional face vs. neutral face), each one displayed on a different side of the screen. A faster reaction to emotional stimuli than to neutral ones indicates a bias of attention towards the emotional face and reflects dysfunction on emotional processing.
Time Frame
DPT at baseline and week 12.
Title
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).
Description
Analyze the cost of several variables, including both treatments (pharmacological and psychological), use of infrastructures and travel costs (only the first inclusion visit will be in person, the subsequent follow-up will be online).
Time Frame
At week 12.
Title
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).
Description
The UKU side effects scale is designed to evaluate the secondary effects derived from the consumption of psychotropic drugs. The UKU scale comprises a total of 54 items that describe 54 side effects. Each item takes a value from 0 to 3 (0, no or doubtful present; 1, mild; 2, moderate; 3, severe).
Time Frame
At week 3, 6, 9 and 12.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cinto Segalàs, MD, PhD.
Organizational Affiliation
Psychiatrist at the Bellvitge University Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catalan Institute of Oncology
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18291293
Citation
Fann JR, Thomas-Rich AM, Katon WJ, Cowley D, Pepping M, McGregor BA, Gralow J. Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):112-26. doi: 10.1016/j.genhosppsych.2007.10.008.
Results Reference
result
PubMed Identifier
24337537
Citation
Vodermaier A, Linden W, Rnic K, Young SN, Ng A, Ditsch N, Olson R. Prospective associations of depression with survival: a population-based cohort study in patients with newly diagnosed breast cancer. Breast Cancer Res Treat. 2014 Jan;143(2):373-84. doi: 10.1007/s10549-013-2795-4. Epub 2013 Dec 13.
Results Reference
result
PubMed Identifier
22123153
Citation
Miguel C, Albuquerque E. Drug interaction in psycho-oncology: antidepressants and antineoplastics. Pharmacology. 2011;88(5-6):333-9. doi: 10.1159/000334738. Epub 2011 Nov 26.
Results Reference
result
Citation
Ochoa, C., & Casellas-Grau, A. (2015). Positive Psychotherapy in Cancer: Facilitating Posttraumatic Growth in Assimilation and Accomodation of Traumatic Experience. In C.R. Martin, V. R. Preedy & B. P.Vinood (Eds.). Comprehensive Guide to Post-Traumatic Stress Disorder (pp.113-127). Verna: Springer International Publishing Switzerland.
Results Reference
result
PubMed Identifier
30124867
Citation
Godlewska BR, Browning M, Norbury R, Igoumenou A, Cowen PJ, Harmer CJ. Predicting Treatment Response in Depression: The Role of Anterior Cingulate Cortex. Int J Neuropsychopharmacol. 2018 Nov 1;21(11):988-996. doi: 10.1093/ijnp/pyy069.
Results Reference
result
PubMed Identifier
21041614
Citation
Victor TA, Furey ML, Fromm SJ, Ohman A, Drevets WC. Relationship between amygdala responses to masked faces and mood state and treatment in major depressive disorder. Arch Gen Psychiatry. 2010 Nov;67(11):1128-38. doi: 10.1001/archgenpsychiatry.2010.144.
Results Reference
result
PubMed Identifier
23809145
Citation
Victor TA, Furey ML, Fromm SJ, Ohman A, Drevets WC. Changes in the neural correlates of implicit emotional face processing during antidepressant treatment in major depressive disorder. Int J Neuropsychopharmacol. 2013 Nov;16(10):2195-208. doi: 10.1017/S146114571300062X. Epub 2013 Jul 1.
Results Reference
result
PubMed Identifier
23588951
Citation
Avis NE, Levine B, Naughton MJ, Case LD, Naftalis E, Van Zee KJ. Age-related longitudinal changes in depressive symptoms following breast cancer diagnosis and treatment. Breast Cancer Res Treat. 2013 May;139(1):199-206. doi: 10.1007/s10549-013-2513-2. Epub 2013 Apr 16.
Results Reference
result
PubMed Identifier
13688369
Citation
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
Results Reference
result
Links:
URL
http://cima.aemps.es/cima/pdfs/es/ft/60884/FT_60884.html.pd
Description
Citalopram technical data sheet.

Learn more about this trial

Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression

We'll reach out to this number within 24 hrs