E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major depressive Disorder, one episode or several episodes. ICD: 296.2x, 296.3x |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |