Clinical trial NCT05063604: Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Major Depressive Episode
Keywords: Breast Cancer
Major Depressive Episode
Antidepressant Efficacy
Psychotherapy
Citalopram
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Institut Català d'Oncologia
First posted: 2021-10-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
timeFrame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Secondary outcomes:
measure: 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.
timeFrame: Baseline and week 12.
measure: Change from Baseline in social-labor adaptation measured by number of days off work at week 12.
timeFrame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
measure: Age of patients.
timeFrame: Baseline.
measure: Marital status.
timeFrame: Baseline.
measure: Cancer treatment received.
timeFrame: Baseline.
measure: Breast cancer stage.
timeFrame: Baseline.
measure: Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).
timeFrame: fMRI at baseline.
measure: Change from baseline in emotional processing on the Dot-Probe Task (DPT).
timeFrame: DPT at baseline and week 12.
measure: 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).
timeFrame: At week 12.
measure: 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).
timeFrame: At week 3, 6, 9 and 12.
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Catalan Institute of Oncology
state: Barcelona
Study officials:
affiliation: Psychiatrist at the Bellvitge University Hospital.
name: Cinto Segalàs, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.