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

Hospital Universitari de Bellvitge1 site in 1 country40 target enrollmentMay 10, 2022

ConditionsBreast Cancer Major Depressive Episode

InterventionsCitalopram Psychotherapy

DrugsCitalopram

Overview

Phase: Phase 2
Intervention: Citalopram
Conditions: Breast Cancer
Sponsor: Hospital Universitari de Bellvitge
Enrollment: 40
Locations: 1
Primary Endpoint: Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

clinicaltrials.gov

Start Date

May 10, 2022

End Date

June 29, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Hospital Universitari de Bellvitge

Responsible Party

Principal Investigator

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).

Hospital Universitari de Bellvitge

Eligibility 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 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 .

Arms & Interventions

Citalopram 20-40 mg

Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.

Intervention: Citalopram

Psychotherapy

Participants received one psychotherapy session weekly for 12 weeks.

Intervention: Psychotherapy

Outcomes

Primary Outcomes

Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.

Time Frame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).

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.

Secondary Outcomes

Cancer treatment received.(Baseline.)
Number and severity of secondary side effects related to the consumption of pharmacological treatment with citalopram according to the side effects rating scale Udvalg für Kliniske Undersogelser (UKU).(At week 3, 6, 9 and 12.)
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).)
Marital status.(Baseline.)
Breast cancer stage.(Baseline.)
Age of patients.(Baseline.)
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).(fMRI at baseline.)
Cost-effectiveness ratio differences between pharmacological treatment with citalopram and psychological treatment in patients in our environment with breast cancer (BC) and major depression (MD).(At week 12.)
Change from baseline in emotional processing on the Dot-Probe Task (DPT).(DPT at baseline and week 12.)