E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Indication: Major Depressive Disorder according to the DSM-IV-TR |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009710 |
E.1.2 | Term | CNS depression |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
·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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |