Major depressive Disorder, one episode or several episodes. ICD: 296.2x, 296.3x
Conditions
Interventions
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: 1
Sponsors
Servicio de psiquiatria. Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Acute or chronic organic disorder 2. Psychotic disorder 3. history of drug or alcohol abuse or dependency 4. severe or moderate hepatic or renal disease 5. pregnancy or lactation Patients will be excluded whenever: 1. the patient express his/her wish to finish the study 2. because of severe side effects 3. because of increasing depressive symptomatology, no response to antidepressant treatment or serious suicide risk. 4. the patient don´t take the medication or not assissting to the following visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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 | — |
Countries
Spain
Outcome results
None listed