Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
NCT ID: NCT05063604
Last Updated: 2022-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2022-05-10
2022-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Citalopram 20-40 mg
Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.
Citalopram
20 mg tablet one or twice daily for 12 weeks
Psychotherapy
Participants received one psychotherapy session weekly for 12 weeks.
Psychotherapy
One session weekly for 12 weeks
Interventions
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Citalopram
20 mg tablet one or twice daily for 12 weeks
Psychotherapy
One session weekly for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 .
18 Years
75 Years
FEMALE
No
Sponsors
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Institut Català d'Oncologia
OTHER
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Cinto Segalàs Cosi, MD
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).
Principal Investigators
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Cinto Segalàs, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Psychiatrist at the Bellvitge University Hospital.
Locations
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Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Citalopram technical data sheet.
Other Identifiers
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2019-004548-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HUB-PSI-CAMAD
Identifier Type: -
Identifier Source: org_study_id
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