| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Major Depressive Disorder |
|
| 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 |
|
| 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 efficacy of three fixed dosages of Lu AA21004 (2.5 mg, 5 mg or 10 mg daily) versus placebo after 8 weeks of treatment. |
|
| E.2.2 | Secondary objectives of the trial |
To evaluate:
-safety/tolerability of LuAA21004 compared to placebo during the course of treatment
-efficacy of LuAA21004 compared to placebo during the 8-week, double-blind treatment
-proportion of responders to LuAA21004 treatment at week 8 compared to placebo
-proportion of patients in remission after 8 weeks of treatment with LuAA21004 as compared to placebo
-efficacy of LuAA21004 compared to placebo after 1 week of treatment
-proportion of patients who are in sustained response after 1 week of treatment with LuAA21004 compared to placebo
-effect of LuAA21004 on fatigue as assessed by the fatigue severity scale.
-efficacy/safety of duloxetine vs placebo on the same parameters as mentioned for the LuAA21004
-effect of LuAA21004 on Quality of Life, disability and health care resource utilisation
-population pharmacokinetics of Lu AA21004 and its metabolites LuAA34443 and LuAA39835
-effect of LuAA21004 on sexual function as assessed by Arizona Sexual Experiences Scale (ASEX) |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
A patient, who meets all the following criteria, both at the Screening Visit and at the Baseline 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 suffers from 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 Major Depressive Episode is at least 3 months.
5.The patient has a MADRS total score of 26 or higher.
6.The patient is, man or woman, aged between 18 and 75 years (extremes included).
7.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 |
|
| E.4 | Principal exclusion criteria |
A patient who meets one or more of the following criteria at the Screening Visit and/or at the Baseline Visit, is not eligible for inclusion in this study:
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 by the 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 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 score 5 or higher 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 increased intra-ocular pressure or is at risk of acute narrow-angle glaucoma
8. The patient has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, skin and subcutaneous tissue disorders or metabolic disturbance.
9. The patient has a chronic liver disease.
10. The patient has clinically significant abnormal vital signs.
11. The patient has a history of lack of response to previous adequate treatment with duloxetine (including current episode)
12. The patient has a history of severe drug allergy or hypersensitivity, or known hypersentivity to duloxetine
13. 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.
14. The patient has TSH value outside the normal range at Screening Visit.
15. The patient has a clinically significant abnormal ECG.
16. 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.
17. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening.
18. The patient is pregnant or breast-feeding.
19. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
20. The patient is a member of the site personnel or their immediate families.
21. The patient has previously participated in this study.
22. The patient has previously been exposed to Lu AA21004.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Based on the FAS and using LOCF, the change in baseline in MADRS total score at week 8 will be will be used as the primary efficacy parameter. |
|
| 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 | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| 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 | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| 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 | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 42 |
| 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 |
|
| 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
|
| The end of the study for an individual patient is defined as the last protocol-specified contact with a patient. For patients entering into the extension study (11984B) the end of study is defined as the performance of the Completion Visit. The overall end of the study is defined as the last protocol-specific contact with the last patient ongoing in the study. |
|
| 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 | 1 |
| E.8.9.1 | In the Member State concerned days | 7 |
| 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 | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 7 |
Print
