CLINICAL TRIAL TO EVALUATE THE ANTIDEPRESSANT EFFICACY OF PSYCHOTHERAPY AND CITALOPRAM IN WOMEN DIAGNOSED WITH BREAST CANCER AND MAJOR DEPRESSION

A 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. CAMAD PROJECT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004548-31-ES

Enrollment

Registered

2020-01-14

Start date

2020-04-18

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female patients diagnosed with breast cancer who, during the first year following the diagnosis of oncological disease, have affective symptomatology that meets DSM-V criteria for major depression. MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (i

Interventions

Trade Name: PRISDAL 20mg PRISDAL 30mg Product Name: Citalopram Pharmaceutical Form: Tablet INN or Proposed INN: CITALOPRAM CAS Number: 59729-33-8 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

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 of major depression for at least two weeks or adaptive disorder with depressive mood for at least two months, according to DSM-V criteria, during the twelve months following the diagnose of breast cancer. - Minimum score of 14 on the Hamilton Depression Scale (HDRS) - Informed Consent Form Signature Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Women who are pregnant or breastfeeding. • Suicide risk. • Brain metastatic 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 .

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy: -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.;Secondary Objective: Efficacy: -To evaluate the antidepressant effect of the therapeutic treatment studied and Quality life impact. -To evaluate the antidepressant effect of the therapeutic treatments studied and their socio-labour adaptation impact. -To estimate which clinical, sociodemographic and onco-specific treatment variables predict a greater antidepressant response to a specific treatment strategy. Biomarkers: -To study possible functional neuroimaging and emotional processing biomarkers, specific of major depression in breast cancer that could predict the response to a specific therapeutic treatment Safety: -Assess the safety (12 weeks) of the two therapeutic treatments studied: pharmacological treatment (citalopram) and psychotherapy treatment. Objectives pharmaco-economics -To estimate the cost-effectiveness ratio of pharmacological treatment with citalopram regarding psychological treatmen with breast cancer and major depression, as well as its economic impact on back to work.;Primary end point(s): -Antidepressant efficacy: Score on the HDRS scale.;Timepoint(s) of evaluation of this end point: The assessment of the main end point is in visit end of cure.	—

Measure

Time frame

Main Objective: Efficacy: -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.;Secondary Objective: Efficacy: -To evaluate the antidepressant effect of the therapeutic treatment studied and Quality life impact. -To evaluate the antidepressant effect of the therapeutic treatments studied and their socio-labour adaptation impact. -To estimate which clinical, sociodemographic and onco-specific treatment variables predict a greater antidepressant response to a specific treatment strategy. Biomarkers: -To study possible functional neuroimaging and emotional processing biomarkers, specific of major depression in breast cancer that could predict the response to a specific therapeutic treatment Safety: -Assess the safety (12 weeks) of the two therapeutic treatments studied: pharmacological treatment (citalopram) and psychotherapy treatment. Objectives pharmaco-economics -To estimate the cost-effectiveness ratio of pharmacological treatment with citalopram regarding psychological treatmen with breast cancer and major depression, as well as its economic impact on back to work.;Primary end point(s): -Antidepressant efficacy: Score on the HDRS scale.;Timepoint(s) of evaluation of this end point: The assessment of the main end point is in visit end of cure.

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Secondary

Measure	Time frame
Secondary end point(s): Antidepressant efficacy: Quality of life questionnaire score EQ-5D-3L. -Socio-labour adaptation: number of days off work. -Predictive factors: • Sociodemographic endpoints. • Quality of life and social adaptation at the time of diagnosis. • Clinical endpoints: oncological disease stage, onco-specific treatment (surgery, radiotherapy, chemotherapy and/or hormone therapy). •Psychosocial support. Biomarkers: -Functional neuroimaging (functional MR will evaluate the activity of certain brain structures such as ACC) and emotional processing with BMT: Response Predictors. Safety: -Number of patients with medical complications not directly related to the base disease. -Total number of adverse events. -Number of citalopram /psychological treatment related adverse events.;Timepoint(s) of evaluation of this end point: The assessment of the secondary end points is thoughout the study.	—

Measure

Time frame

Secondary end point(s): Antidepressant efficacy: Quality of life questionnaire score EQ-5D-3L. -Socio-labour adaptation: number of days off work. -Predictive factors: • Sociodemographic endpoints. • Quality of life and social adaptation at the time of diagnosis. • Clinical endpoints: oncological disease stage, onco-specific treatment (surgery, radiotherapy, chemotherapy and/or hormone therapy). •Psychosocial support. Biomarkers: -Functional neuroimaging (functional MR will evaluate the activity of certain brain structures such as ACC) and emotional processing with BMT: Response Predictors. Safety: -Number of patients with medical complications not directly related to the base disease. -Total number of adverse events. -Number of citalopram /psychological treatment related adverse events.;Timepoint(s) of evaluation of this end point: The assessment of the secondary end points is thoughout the study.

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Countries

Spain

Contacts

Public ContactCinto Segalàs

Cinto Segalàs

csegalas@bellvitgehospital.cat0034932607922

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026