Major depressive disorder
Conditions
Interventions
Trade Name: Cipralex 10 mg film-coated tablet
Product Name: Escitalopram 10 mg tablets
Product Code: Lu 26-054
Pharmaceutical Form: Film-coated tablet
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any patient who meets all of the following criteria is eligible for inclusion in this study: 1. The patient is able to read and understand the Patient Information Sheet. 2. The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form. 3. The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx) (current episode assessed with the MINI). 4. The patient is an outpatient, male or female. 5. The patient is aged = 18 and = 65 years. 6. The patient has a MADRS total score = 26 at the baseline visit. 7. The patient has a CGI-S score = 4 at the baseline visit. 8. The patient, in the opinion of the investigator, is otherwise healthy on the basis of a physical examination, medical history and vital signs. 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: 1. The patient has previously participated in this study. 2. The patient has a significant risk of suicide according to investigator’s opinion or presents a score =5 on item 10 (suicidal thoughts) of the MADRS. 3. The patient meets DSM-IV-TR criteria (as assessed with the MINI) for: - current Obsessive-Compulsive Disorder, - current Post-traumatic Stress Disorder, - current Panic Disorder, - past or current manic or hypomanic episode, - past or current psychotic symptoms or disorder, - current drug or alcohol abuse or dependence, - current eating disorder (anorexia or bulimia). 4. The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. 5. The patient presents a personality disorder that might compromise the study. 6. The patient has increased intra-ocular pressure or is at risk of acute narrow-angle glaucoma. 7. The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient’s participation in the study, the patient may be included). 8. The patient uses disallowed recent or concomitant medication. 9. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to citalopram, escitalopram, or duloxetine. 10. The patient has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency. 11. The patient is pregnant or breast-feeding. 12. The patient, if a woman of childbearing potential, is not using adequate contraception. 13. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is the change from baseline in MADRS total score at end of Week 24.; Main Objective: To compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. ; Secondary Objective: • To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD. • To compare the tolerability and safety of escitalopram with that of duloxetine over the 24-week study period in outpatients with MDD. • To evaluate the discontinuation emergent signs and symptoms during and after taper-down treatment with escitalopram or duloxetine after 24 weeks of treatment. • To evaluate the impact of treatment with escitalopram or duloxetine on the quality of life in patients with MDD. • To evaluate the utilization of resources in patients with MDD treated with escitalopram or duloxetine. | — |
Countries
Czech Republic, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed