Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Depression

Depressive Disorder

Depressive Disorder, Major

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Psychotropic Drugs

Anti-Dyskinesia Agents

Escitalopram

Citalopram

Antidepressive Agents

Dexetimide

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

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

Psychotherapy

Cinto Segalàs, MD, PhD.

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.

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

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

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.

The EQ-5D-3L is a standardized measure of health-related quality of life. The EQ-5D descriptive system comprises five dimensions with three levels of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.

Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.

Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.

Breast cancer stage is expressed as a number on a scale from 0 to IV, where 0 describes non-invasive cancers that remain within their original location, and IV describes invasive cancers that have spread outside the breast to other parts of the body. This clinical information will be collected from the medical record.

fMRI is a specialized form of magnetic resonance imaging used to examine regional brain activity, allowing the identification of the brain areas allegedly underpinning psychological processes. fMRI uses a specific imaging sequence (echo planar imaging) to measure small changes in blood oxygenation by assessing the so-called blood oxygenation level dependent (BOLD) signal over time, which is linked to regional neuronal function.

The DPT is a validated task to assess emotional processing by measuring reaction time to two types of stimuli (emotional face vs. neutral face), each one displayed on a different side of the screen. A faster reaction to emotional stimuli than to neutral ones indicates a bias of attention towards the emotional face and reflects dysfunction on emotional processing.

Analyze the cost of several variables, including both treatments (pharmacological and psychological), use of infrastructures and travel costs (only the first inclusion visit will be in person, the subsequent follow-up will be online).

The UKU side effects scale is designed to evaluate the secondary effects derived from the consumption of psychotropic drugs. The UKU scale comprises a total of 54 items that describe 54 side effects. Each item takes a value from 0 to 3 (0, no or doubtful present; 1, mild; 2, moderate; 3, severe).

Institut Català d'Oncologia

Hospital Universitari de Bellvitge

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression	NCT05063604	Breast Cancer Major Depressiv...	Citalopram Psychotherapy	18 Years - 75 Years	Hospital Universitari de Bellvitge
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression	NCT05063604	Breast Cancer Major Depressiv...	Citalopram Psychotherapy	18 Years - 75 Years	Hospital Universitari de Bellvitge

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