The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.
CAMAD
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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
40
1 country
1
Study Start
May 10, 2022
Actual (reported)Primary Completion
May 10, 2022
Actual (reported)Study Completion
June 29, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 27, 2021
Actual (reported)October 1, 2021
Actual (reported)May 10, 2022
Actual (reported)May 10, 2022
Actual (reported)June 29, 2022
Actual (reported)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).
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.
Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.
Participants received one psychotherapy session weekly for 12 weeks.
20 mg tablet one or twice daily for 12 weeks
One session weekly for 12 weeks
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
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.
Cinto Segalàs, MD, PhD.
Psychiatrist at the Bellvitge University Hospital.
40 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2021
First Posted
October 1, 2021
Study Start
May 10, 2022
Actual (reported)Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
May 10, 2022
Actual (reported)Study Completion
June 29, 2022
Actual (reported)Last Updated
July 5, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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