A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of Lu AA21004 (15 and 20 mg/day) in the acute treatment of adult patients with Major Depressive Disorder. - Not applicable
- Conditions
- Major Depressive DisorderMedDRA version: 12.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSMedDRA version: 12.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episode
- Registration Number
- EUCTR2009-017523-26-LV
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. The patient is able to read and understand the Informed Consent Form.
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 has recurrent Major Depressive Disorder (MDD) as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x). The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
4. The patient has a MADRS total score >26.
5. The patient has a CGI-S score >4.
6. The reported duration of the current MDE is >3 months.
7. The patient is a man or woman, aged >18 and <75 years.
8. The patient, if a woman, must:
- agree not to try to become pregnant during the study, AND
- use adequate, highly effective contraception (defined as those that result in a low failure rate [that is, <1% per year] when used consistently and correctly, for example, implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, vasectomised partner), OR
- have had her last natural menstruation at least 24 months prior to the Screening Visit, OR
- have been surgically sterilised prior to the Screening Visit, OR
- have had a hysterectomy prior to the Screening Visit.
9. The patient is willing and able to attend study appointments within the specified time windows.
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
The patient:
1. has previously participated in this study.
2. is a member of the site personnel or their immediate families.
3. is pregnant or breast-feeding.
4. has a history of severe drug allergy or hypersensitivity, or knownhypersensitivity to duloxetine.
5. The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
6. has a history of lack of response to previous adequate treatment with duloxetine (including current episode).
7. has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency.
8. has any current anxiety psychiatric disorder (DSM-IV-TR™ criteria), as assessed using the Mini International Neuropsychiatric Interview (MINI).
9. has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
10. has a current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) (DSM-IV-TR™ criteria).
11. has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
12. has a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are likely to affect central nervous system functioning.
13. has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of IMP.
14. has a clinically significant unstable illness, for example:
- neurological/neurodegenerative disorder
- cardiovascular disease
- seizure disorder or encephalopathy
- congestive heart failure
- cardiac hypertrophy
- arrhythmia
- bradycardia (pulse <50 bpm)
- respiratory disease
- hepatic impairment or renal insufficiency
- metabolic disorder
- endocrinological disorder
- gastrointestinal disorder
- haematological disorder
- infectious disorder
- any clinically significant immunological condition
- dermatological disorder
- venereal disease
15. has a chronic liver disease.
16. takes or has taken disallowed recent or concomitant medication (specified in Appendix II) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
17. has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to the Screening Visit.
18. has elevated intra-ocular pressure or is at risk of acute narrow-angle glaucoma.
19. has clinically significant abnormal vital signs at the Screening Visit.
20. has one or more laboratory values outside the reference range, based on the blood or urine samples taken at the Screening Visit, that are, in the investigator’s opinion, of potential risk to the patient’s safety, or the patient has any of the following values at the Screening Visit:
- a serum creatinine value >1.5 times the upper limit of the reference range
- a serum total bilirubin value >1.5 times the upper limit of the reference range
- a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 times the upper limit of the reference range
- a plasma prothrombin tim
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method