Randomised, double-blind, parallel-group, placebo-controlled, duloxetine referenced, dose-finding study of Lu AA24530 in Major Depressive Disorder
- Conditions
- Major Depressive DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression
- Registration Number
- EUCTR2007-001071-11-SE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 625
The patient is able to read and understand the Patient Information Sheet.
The patient has signed the Informed Consent Form.
The patient has a Major Depressive Episode (MDE), diagnosed according to DSM-IV-TR criteria (classification code 296.xx) and confirmed according to the Mini-International Neuropsychiatric Interview (MINI) .
The patient is a man or a woman, aged between 18 and 65 years (extremes included).
The patient has a Major Depressive Episode that has lasted at least 3 months.
The patient has a MADRS of total score = 26.
The patient is able to swallow capsules.
The patient, if female, must: agree not to try to become pregnant during the study, AND use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR have had her last natural menstruation at least 24 months prior to Baseline, OR have been surgically sterilised prior to Baseline, OR have had a hysterectomy prior to Baseline, OR not be sexually active.
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
The patient has one or more of the following conditions: Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and assessed with the Mini-International Neuropsychiatric Interview (MINI), current or past 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 as defined in the DSM-IV-TR, any substance use disorder (except nicotine) within the previous 6 months as defined in the DSM-IV-TR, presence or history of a clinically significant neurological disorder, any axis II disorder that might compromise the study.
The patient is at significant risk of suicide either corroborated by MINI item A3g, a score =5 on item 10 on the MADRS (Item No 10), a score of =3 on item 3 of the HAM-D-17 wih MES (Item No 3), or according to investigator’s opinion.
The patient has a Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment of each at least 6 weeks duration.
The patient has a history of lack of response to previous treatment with duloxetine.
The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to duloxetine.
The patient has received electroconvulsive therapy within 6 months prior to Baseline.
The patient used/uses 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.
The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance.The patient has increased intra-ocular pressure or is at risk of acute narrow-angleglaucoma.The patient has a chronic liver disease.
The patient has abnormal vital signs judged by the investigator to be indicative of significant illness.
The patient has a history of seizures.
The patient has a history of renal illness or damage or decreased renal function.
The patient has one or more laboratory values outside the normal range, based on the blood samples taken at the Screening Visit, that are considered by the investigator to be indicative of significant illness.
The patient has a thyroid-stimulating hormone (TSH) out of normal range
The patient has an abnormal ECG judged by the investigator to be indicative of significant illness.
The patient has a QTc above 450 ms.
The patient has a history of hypokalaemia.
The patient has a family history of Long QT Syndrome.
The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to Baseline.
The patient has a positive urine drug screen.
The patient is pregnant or breast-feeding.
The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
The patient is a member of the site personn
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