Indication: Major Depressive Disorder according to the DSM-IV-TR MedDRA version: 9.1 Level: LLT Classification code 10009710 Term: CNS depression
Conditions
Interventions
Product Name: Lu AA21004
Product Code: Lu AA21004
Pharmaceutical Form: Tablet
INN or Proposed INN: 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine-hydrobromide
Current Sponsor code: Lu AA21004
C
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who meets all the following criteria is eligible for inclusion into this study: 1. The patient is able to read and understand the Subject Information Sheet for the present study, which is different from the one for study 11492A. 2. The patient has signed the new Informed Consent Form, which is separate from the signed informed consent obtained for the study 11492A. 3. The patient must have completed study 11492A (visit 10; end of down taper) immediately prior to enrolment into this extension study. 4. The patient had a documented primary diagnosis of M D E at entry into study 11492A . 5. 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 6. The patient, on the basis of electrocardiogram, blood biochemistry, haematology test and a urinalysis carried out at the visit 8 of the previous study and on the investigator’s opinion, is otherwise healthy. 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. Patients meeting any of the exclusion criteria applying for patients at entry to study 11492A, except criteria 10 (hypertension), 15 (previous exposure to investigational drug), and 21(previous exposure to Lu AA21004). 2. The patient with MDD for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia or any psychotic disorder) have been diagnosed during study 11492A. 3. The patient has, in the investigator’s opinion a significant risk of suicide, and/or a score of ³ 5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS). 4. The patient is in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol or is unsuitable for any other reasons. 5. The patient has a clinically significant, moderate or severe ongoing adverse event, related to study medication from study 11492A. 6. The patient has used/ uses disallowed recent or concomitant medication (specified in appendix Recent and Concomitant medication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective:- to evaluate the long-term safety and tolerability of flexible-doses of Lu AA21004 (5mg or 10mg daily) over a period of 52 weeks in patients with Major Depressive Disorder, who completed short-term study 11492A.;Secondary Objective: ·Secondary objectives:- to evaluate the therapeutic effect of flexible-doses of Lu AA21004 (5mg or 10mgdaily) over a period of 52 weeks in patients with Major Depressive Disorder, who completed short term study 11492A. Additional objectives: - to evaluate the effect of Lu AA21004 on Health Related Quality of Life as measured by SF-36 acute (1 week recall) version and EuroQoL scales. - to evaluate the population pharmacokinetics of Lu AA21004 and it’s metabolite.;Primary end point(s): Safety is the primary endpoint in the present study. The measurements include vital signs, ECGs, laboratory tests, weight, physical examinations, adverse events and withdrawal rates. | — |
Countries
Czech Republic, Finland, Italy, Sweden
Outcome results
None listed