A double-blind, randomised, placebo-controlled, multicentre, relapse-prevention study with two doses of Lu AA21004 in patients with Major Depressive Disorder. - Not applicable
- Conditions
- Major Depressive DisoderMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS
- Registration Number
- EUCTR2007-001871-13-BE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
A patient who meets all the following criteria, both at the Screening Visit and at the Baseline I Visit, is eligible for inclusion in this study:
1.The patient is able to read and understand the Subject 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 has a major depressive episode (MDE) as the primary diagnosis according to DSM-IV TR criteria (classification code 296.xx).
4.The reported duration of the current MDE is at least 4 weeks.
5.The patient had at least one other MDE before the current episode.
6.The patient has a MADRS total score equal or higher than 26
7.The patient is man or woman, aged between 18 and 75 years (extremes included).
8.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 with men
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
1.The patient has one or more of the following conditions:
-Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (assessed with the M.I.N.I.).
-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 disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
-Presence or history of a clinically significant neurological disorder (including epilepsy).
-Neurodegenerative disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington´s disease, etc.).
-Any axis II disorder that might compromise the study.
2.The patient has a significant risk of suicide according to the investigator’s opinion or has a score equal or higher than 5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
3.The current depressive symptoms of the patient are considered by the investigator to have been resistant to two adequate antidepressant treatments of at least 6 weeks duration.
4.The patient has used or uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant Medication), or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
5.The patient has received electroconvulsive therapy within 6 months prior to screening.
6.The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
7.The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, skin and subcutaneous tissue disorders or metabolic disturbance.
8.The patient has clinically significant abnormal vital signs.
9.The patient has a history of severe drug allergy or hypersensitivity, or clinically significant lactose intolerance.
10.The patient has one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
11.The patient has TSH value outside the normal range at Screening Visit.
12.The patient has a clinically significant abnormal ECG.
13.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.
14.The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening.
15.The patient is pregnant or breast-feeding.
16.The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
17.The patient is a member of the site personnel or their immediate families.
18.The patient has previously participated in this study.
19.The patient has previously been exposed to Lu AA21004.
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