E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
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 determine the long-term safety and tolerability of DVS SR in children and adolescents with major depressive disorder (MDD). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of DVS SR in the treatment of MDD in children and adolescents in an exploratory manner. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000-US, and who, in the opinion of the investigator, would benefit from long-term treatment.
2.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article.
3.For sexually active subjects, the signed and dated informed consent and assent forms should reflect an awareness of the stipulations concerning the use of contraception. For sexually active subjects, condoms should be used in addition to other contraceptive methods for the duration of study participation and for 15 days after the last dose of test article in order to provide protection against sexually transmitted diseases and to provide additional protection against accidental pregnancy. It is important that subjects not become pregnant or impregnate others while they are in the study.
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E.4 | Principal exclusion criteria |
1.Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of study 3151A6-2000-US. If an exception for an underlying illness was granted for entry into 3151A6-2000-US and if the condition remains stable (ie, no exacerbation), then the subject may enter this 6-month extension study provided that the exception is discussed with and granted by the medical monitor before study entry.
2.Unresolved clinically significant adverse events or serious adverse events in study 3151A6-2000-US.
3.Meets any of the exclusion criteria listed for study 3151A6-2000-US.
4.Poor compliance with protocol 3151A6-2000-US, as assessed by the investigator and the medical monitor.
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)-Baseline (Extension study) up to Extension study Week 29 Follow up visit
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories-Post baseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (Extension study) up to Extension study Week 29 Follow up visit
Post baseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | 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) | 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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA 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.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 18 |