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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05063604
• Other study ID #: HUB-PSI-CAMAD
• Secondary ID: 2019-004548-31
• Status: Terminated
• Phase: Phase 2
• Start date: May 10, 2022
• Est. completion date: June 29, 2022

Study information

• Verified date: June 2022
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 29, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Major Depressive Episode

Intervention

Drug:
• Citalopram
20 mg tablet one or twice daily for 12 weeks

Behavioral:
• Psychotherapy
One session weekly for 12 weeks

Locations

Country	Name	City	State
Spain	Catalan Institute of Oncology	L'Hospitalet De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. Epu — View Citation

BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. — View 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. Review. — View 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. — View 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. Review. — View 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 S

Victor TA, Furey ML, Fromm SJ, Öhman 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/S14 — View 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. — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Secondary	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.	Baseline and week 12.
Secondary	Change from Baseline in social-labor adaptation measured by number of days off work at week 12.	Number of days off work.	Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Secondary	Age of patients.	Measured in years.	Baseline.
Secondary	Marital status.	Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.	Baseline.
Secondary	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.	Baseline.
Secondary	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.	Baseline.
Secondary	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.	fMRI at baseline.
Secondary	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.	DPT at baseline and week 12.
Secondary	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).	At week 12.
Secondary	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).	At week 3, 6, 9 and 12.

External Links

•   Citalopram technical data sheet.