E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder
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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 | 10025453 |
E.1.2 | Term | Major depressive disorder NOS |
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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 |
-to evaluate the long term safety and tolerability of flexible doses of Lu AA21004 (2.5mg, 5mg, or 10mg/day) over a period of 52 weeks in patients with Major Depressive Disorder, having completed the 8 week short-term treatment study 11984A. |
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E.2.2 | Secondary objectives of the trial |
-to evaluate the maintenance of therapeutic effect of flexible doses of Lu AA21004 (2.5mg, 5mg, or 10mg/day) over a period of 52 weeks in patients with Major Depressive Disorder, having completed the short-term study 11984A. -to evaluate the effect of Lu AA21004 on Health Related Quality of Life, disability and health care resource utilisation. -to evaluate the population pharmacokinetics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835. |
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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 in this study:
1.The patient is able to read and understand the Subject Information Sheet for the present study, different from the one for study 11984A. 2.The patient has signed the new Informed Consent Form, which is separate from the signed informed consent obtained for the study 11984A. 3.The patient must have completed study 11984A (Visit 7: Week 8) immediately prior to enrolment into the extension study. 4.The patient had a documented primary diagnosis of a Major Depressive Episode (MDE) at entry in study 11984A. 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 with men 6.The patient is indicated 12-month continuation treatment with Lu AA21004 according to the clinical opinion of the investigator.
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E.4 | Principal exclusion criteria |
In addition to the exclusion criteria applying for study 11984A (appendix V), and which are met at baseline visit, except criteria: -7 (increased intra-ocular pressure or at risk of acute narrow-angle glaucoma -9 (chronic liver disease) -11 (history of lack of response to previous adequate treatment with duloxetine) -17 (previous exposure to investigational drug) -22 (previous exposure to Lu AA21004)
Patients who meet one or more of the following criteria are not eligible for inclusion in this study: 1.The patient with Major Depressive Disorder, for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia or any psychotic disorder) have been diagnosed during study 11984A. 2.The patient, in the investigator’s opinion has a significant risk of suicide, and/or a score of 5 points or higher on item 10 (suicidal thoughts) of the MADRS. 3.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. 4.The patient has a clinically significant, moderate or severe ongoing adverse event, related to study medication in study 11984A. 5.The patient has used/ uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant medication).
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety is the primary endpoint as measured by vital signs, ECGs, laboratory measurements, weight, physical examination, 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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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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The End of the trial is defined as the last protocol-specific contact with the last patient including the safety follow-up visit/contact. |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | |
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 | 11 |