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

  • End date
    Sep 6, 2023
  • participants needed
  • sponsor
    Hospital Universitari de Bellvitge
Updated on 6 October 2021


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.

Condition Breast Cancer, Major Depressive Episode, Breast Cancer Diagnosis, breast carcinoma, cancer, breast, major depressive disorder, single episode
Treatment citalopram, Psychotherapy
Clinical Study IdentifierNCT05063604
SponsorHospital Universitari de Bellvitge
Last Modified on6 October 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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