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

Catalan Institute of Health

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Major Depressive Episode

Treatments: Behavioral: Psychotherapy; Drug: Citalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT05063604

HUB-PSI-CAMAD

2019-004548-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Citalopram 20-40 mg

Experimental group

Description:

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

Treatment:

Drug: Citalopram

Psychotherapy

Experimental group

Description:

Participants received one psychotherapy session weekly for 12 weeks.

Treatment:

Behavioral: Psychotherapy