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

NCT05063604 | Terminated Phase 2 DMC

• 2 other identifiers: HUB-PSI-CAMAD2019-004548-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Major Depressive Episode

Keywords

Breast Cancer; Major Depressive Episode; Antidepressant Efficacy; Psychotherapy; Citalopram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

  Baseline and week 12.

• Change from Baseline in social-labor adaptation measured by number of days off work at week 12.

  Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).

• Age of patients.

  Baseline.

• Marital status.

  Baseline.

• Cancer treatment received.

  Baseline.

Study Arms (2)

Citalopram 20-40 mg

EXPERIMENTAL

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

Drug: Citalopram

Psychotherapy

EXPERIMENTAL

Participants received one psychotherapy session weekly for 12 weeks.

Behavioral: Psychotherapy

Interventions

Citalopram DRUG

20 mg tablet one or twice daily for 12 weeks

Also known as: Prisdal

Citalopram 20-40 mg

Psychotherapy BEHAVIORAL

One session weekly for 12 weeks

Psychotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut Català d'Oncologia: collaborator

Study Sites (1)

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (9)

• 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.

  PMID: 18291293 RESULT

• 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.

  PMID: 24337537 RESULT

• 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.

  PMID: 22123153 RESULT

• 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.

  RESULT

• 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.

  PMID: 30124867 RESULT

• 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.

  PMID: 21041614 RESULT

• 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.

  PMID: 23809145 RESULT

• 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.

  PMID: 23588951 RESULT

• 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.

  PMID: 13688369 RESULT

Related Links

• Citalopram technical data sheet.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Citalopram; Psychotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Behavioral Disciplines and Activities

Study Officials

• Cinto Segalàs, MD, PhD.

  Psychiatrist at the Bellvitge University Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist at the Bellvitge University Hospital. Researcher at the Bellvitge Biomedical Research Institute (IDIBELL). Associate professor at the Clinical Sciences Department of the Barcelona University (UB).

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: October 1, 2021
• Study Start: May 10, 2022
• Primary Completion: May 10, 2022
• Study Completion: June 29, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)