Major depressive disorder (episode or recurrent), moderately severe as principal DSM-IV diagnosis. MedDRA version: 9.1 Level: LLT Classification code 10012378 Term: Depression
Conditions
Interventions
Trade Name: Cymbalta
Product Name: duloxetine
Product Code: Cymbalta
Pharmaceutical Form: Capsule, hard
Sponsors
Eli Lilly Nederland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PHQ-9 > 9 (first screening) actual screening Principal DSM-IV diagnosis: major depressive disorder (episode or recurrent), moderately severe. IDS-SR30 score > 22 Age 18-65 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Too ill, according to GP’s judgement immediate start treatment or transfer to outpatient department is necessary. Indication for immediate crisis intervention or hospital admittance due to e.g severe suicidal risk, serious suicidality or severe psychotic symptoms Medical contraindications for duloxetine Use of antipsychotic medication or mood stabilizers Drug abuse or dependence in the past six months Current use of any hard drug or cannabis (more than 3 units a week) More than 4 units of alcohol per day Pharmacological drugs that influence psychic functions Pregnancy and breast feeding Use of St John's worth (hypericum perforatum) Inability to participate in case of to severe language barrier Patient follows psychotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is assessing the depressive symptom reduction rate of mono-treatment (PST) compared to combined treatment (PST and duloxetine) in patients with major depressive disorder. In other words, testing the hypothesis that combined treatment is more effective than mono-treatment in patients with major depressive disorder.;Secondary Objective: 1. are there intervening variables such as somatic symptoms that interact with the treatment condition? 2. temporal relationship between the reduction of depressive symptoms and somatic symptoms. 3. does providing a structured way of assisting patients with their difficulties by PST will enhance adherence to pharmacotherapy (see protocol) 4. does PST will enhance of the sense of mastery and coping in MDD patients ? 5. do other characteristics, such as demographic variables, depression characteristics (severity and duration) and co morbidity predict a different outcome for either treatment condition. 6. what are the effects of the interventions on symptom reduction rates and the quality of life 12 months after the beginning of the treatment. ;Primary end point(s): 50% reduction at IDS-SR30 score from baseline to study periods’ endpoint | — |
Countries
Netherlands
Outcome results
None listed