E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Depressive disorder not responding to an adequate dose of an antidepressant |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025470 |
E.1.2 | Term | Major depressive disorder, single episode, unspecified degree |
|
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 |
Aims To investigate the effectiveness and tolerability of Aripiprazole as an add-on strategy in patients suffering from recurrent depressive disorder (DSMIV criteria) and not responding to an adequate dose of an antidepressant
Primary Objectives -1- HAM-D17 (Hamilton rating scale for depression) 17-item clinician-rated scale that is designed to measure the severity of illness among patients already diagnosed with depression.
-2- MADRS (Montogmery Asberg Depression Rating scale for severity) 10-item clinician-rated scale that focuses on severity of psychological symptoms and is designed to be sensitive to change over time. Thus it is particularly useful in identifying treatment effects. 3- Remission is defined as minimal or no symptoms as reflected by HAM-D17 total of 7 or less -4- Response rate is defined as at least 50% decrease from baseline to endpoint on HAM-D17 total score
|
|
E.2.2 | Secondary objectives of the trial |
-1- CGI of severity (CGI-S) in the presence of the subject, to record the severity of the illness at the time of assessment, the score ranges from 1 (normal, not ill at all) to 7 (among the most extremely ill patients)
-2- The patients Global Impression of improvement (PGI-improvement)- a patient-rated instrument that measures the improvement of the patient’s symptoms. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse)
-3- To evaluate the incidence of adverse events during the study measured by spontaneously reported adverse events.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Meets criteria for Major depressive disorder by DSM IV -Currently on an adequate dose (within BNF limits) of an antidepressant for at least 6 weeks with and/or other augmentation therapy including lithium and carbamezepine but not antipsychotic medication -Have Hamilton Depression rating Scale (HAMD17) total score of >15 - Agrees to use an effective form of contraception throughout the study
|
|
E.4 | Principal exclusion criteria |
- Pregnant - DSM IV defined history of substance abuse or dependence within the past year - Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurological disease, including uncontrolled seizure disorder) - History of or current psychotic features - Patients should not have been on an antipsychotic medication in the past 2 weeks -Patients who are receiving psychotherapy
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Remission is defined as minimal or no symptoms as reflected by HAM-D17 total of 7 or less - Response rate is defined as at least 50% decrease from baseline to endpoint on HAM-D17 total score
|
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 36 |