Comparación de dos estrategias de intervención para el tratamiento de los trastornos depresivos en pacientes oncológicos

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Cipralex Product Name: cipralex Pharmaceutical Form: Capsule* INN or Proposed INN: ESCITALOPRAM Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 10‐20 CONDITION: Major depressive Disorder, one episode or several episodes. ICD: 296.2x, 296.3x PRIMARY OUTCOME: Main Objective: To compare the efficacy of two treatments with drug therapy versus drug therapy plus psychotherapy on depressive symptomatology and on quality of life in a sample of oncological patients at 12, 24 and 48 weeks. Primary end point(s): Main dependent variables:; 1. An increase of 20 in global score of quality of life measured by EORTC‐QLQ ; C30 in the group of patients treated with drug and psychotherapy at 24; and 48 week compared with basal situation; 2. A decrease of 25 % in depressive symptomatology measured by ; Montgomery Asberg at 24 and 48 week .; ; Secondary dependent variable:; Quality of life of the principal caregiver measured by SF‐36.; ; Independent variables; 1. Personality measured by the TCI‐R short version. The instrument ; evaluates 7 dimensions.; 2. Coping strategies; 3. sociodemographic data; 4. stage of cancer; 5. time since diagnosis of cancer; 6. current chemotherapy or radiotherapy treatment; 7. life events; 8. presence of pincipal caregiver; 9. Type of cancer; ; Secondary Objective: 1. To compare the efficacy of two treatment with drug therapy versus drug therapy plus psychotherapy on depressive symptomatology and on quality of life in a sample of oncological patients at 12, 24 and 48 weeks on quality of life in a sample of principal caregivers of oncological patients at ; 2. To assess the influence of psychosocial variables (personlaity, coping strategies, vital events, having a principal caregiver) on outcome variables.; ; INCLUSION CRITERIA: 1. Men and women with a range of age 18‐75 years. 2. Diagnosis of colon, breast or lung cancer with a life expectative of more than one year. 3. Karnofsky index greater or equal to 70 4. diagnosis of Depressive disorder according to criterir DSM‐IV 5. Patients with written informed consent to participate in the study after having been provided a complete description ot the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 61d05555c4e1666a79ea0210e9fc31ca9cf436fe
First added on: Aug 21, 2024