Major Depressive Disorder MedDRA version: 21.1 Level: LLT Classification code 10081270 Term: Major depressive disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Trittico XR 150 mg prolonged-release tablets
Product Name: Trittico XR 150 mg prolonged-release tablets
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: TRAZODONE
CAS Num
Sponsors
Angelini Pharma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female patients of any ethnic origin between 18 and 64 years of age (limits included). 2. Outpatients with non-metastatic breast cancer under endocrine therapy. The primary diagnosis of breast cancer must be confirmed by appropriate clinical and instrumental assessment. 3. Outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis, experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score =20 at Baseline Visit. 4. Patients eligible to start treatment with trazodone once-a-day monotherapy at Baseline Visit. In case of switch from other antidepressant drug, the related tapering schedule should be completed at the time of study inclusion. 5. Women of childbearing potential and women with no menses for a period =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients who meet any of the contraindications to the administration of trazodone once-a-day according to the approved local SmPC. 2. Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication. 3. Patients with locally advance or metastatic breast cancer or receiving adjuvant chemotherapy. 4. Concomitant treatment with other antidepressant drugs (use is forbidden for the whole study duration) and/or proved resistance to the trazodone once a- day monotherapy. 5. Patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders or mental disorders due to a general medical condition. 6. Patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative disease, or other relevant condition (e.g. heart disease) that, in the opinion of the Investigator, might compromise participation in the study. 7. Patients who are at risk of suicide defined by a score =4 in MADRS item #10 at Baseline Visit. 8. Women during pregnancy or lactation period. 9. Clinically significant abnormalities on physical examination, vital signs and/or laboratory values (as assessed per routine clinical practice) at Baseline Visit which, in the opinion of the Investigator, could interfere with the study procedures or endpoints evaluation. 10. Patients with known cardiovascular disease including those associated to the prolongation of the QT interval (e.g. QTcF value higher than 450 msec for male and QTcF value higher than 470 msec for female) 11. Suspicious or confirmed COVID-19 infection according to the patient’s symptoms at the time of Baseline Visit. 12. Inability to comply with the protocol requirements (i.e. uncooperative attitude, inability to return to study visits, unlikelihood of completing the clinical study). 13. Subject involved in the conduct of the study (e.g. Investigator or her deputy, first grade relatives, pharmacist, assistant or other personnel). 14. Participation to an interventional clinical trial within 3 months of Baseline Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of trazodone once-a day monotherapy in improving depression symptoms in patients with breast cancer and co-morbid major depressive disorder after 8-week treatment period.;Secondary Objective: To assess the patient’s evaluation of depressive symptoms, functional recovery including cognitive and behavioural responses, quality of life, the compliance of antidepressant treatment, and safety over the 12-weeks study period.;Primary end point(s): The mean change in Montgomery-Asberg Depression Rating Scale (MADRS) score from Baseline Visit to Visit 3.;Timepoint(s) of evaluation of this end point: Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -mean changes in MADRS score from Baseline Visit to Visits 1, 2 and 4 -changes in the distribution of Clinical Global Impression (CGI) from Baseline Visit to Visits 1, 2, 3 and 4 -mean changes in Brief Symptom Inventory modified version (BSI-18 MOD) total score from Baseline Visit to Visits 1, 2, 3 and 4 -changes in the distribution of Insomnia Severity Index (ISI) from Baseline Visit to Visits 1, 2, 3 and 4 -mean changes in Biological Rhythms Interview for Assessment in Neuropsychiatry (BRIAN) total score from Baseline Visit to Visit 4 - mean changes in Mini-Mental Adjustment to Cancer Scale (Mini-MAC) total score from Baseline Visit to Visits 3 and 4 - changes in EuroQuality of Life 5 dimensions – 5 level (EQ-5D-5L) and mean changes in the Visual Analogue Scale (VAS) from Baseline Visit to Visits 3 and 4 comparison between MADRS, BSI-18 MOD, Mini-MAC and VAS of EQ-5D-5L at Baseline Visit, Visit 3 and Visit 4 -compliance to antidepressant treatment (calculated as number of trazodone once-a-day tablets taken by patient since Baseline Visit until the last day of medication) -changes in concomitant medications for treatment of depression over the 12-weeks study period - safety evaluation;Timepoint(s) of evaluation of this end point: -Visit 1,2 and 4 -Visit 1,2,3 and 4 -Visit 1,2,3 and 4 -Visit 1,2,3 and 4 -Visit 4 -Visit 3 and 4 -Visit 3 and 4 -Visit 3 and 4 -last day of medication -12 weeks -12 weeks | — |
Countries
Bulgaria
Contacts
Public ContactGlobal Medical Department
Angelini Pharma S.p.A.
Outcome results
None listed