E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalised Anxiety Disorder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 3.3 |
E.1.2 | Level | P.T. |
E.1.2 | Classification code | 10018075 |
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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 |
The primary objective of this study is to assess the efficacy of agomelatine compared to placebo, after a 12-week orally treatment in out-patients suffering from Generalised Anxiety Disorder (GAD) using the Hamilton Anxiety Rating Scale (HAM-A).
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to provide additional safety and tolerability data on agomelatine. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patient fulfilling DSM-IV-TR criteria for Generalized Anxiety Disorder with a HAM-A total score of at least 22 and a MADRS total score not more than or equal to 16
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E.4 | Principal exclusion criteria |
Related to anxiety : - all types of anxiety disorders other than Generalized Anxiety Disorder such as Panic Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Acute Stress Disorder, Agoraphobia, Social phobia, - insight-oriented and structured psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioral therapy) started within the 3 months before inclusion. Related to other psychiatric conditions : - patients meeting DSM-IV-TR current diagnosis of any Psychiatric Disorder other than GAD (within 6 months) or a previous lifetime diagnosis of Bipolar Disorder, Psychotic Disorder, - patients with a severe personality disorder other than antisocial, borderline or histrionic and prone to interfere with the evaluation of the study according to the investigator’s judgement, - patients who have a suicide risk according to the investigator's judgment or score > 2 on the MADRS item 10 or have made a suicide attempt within the last year. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main expression of the primary efficacy criterion: - HAM-A total score expressed in terms of last post-baseline value.
Secondary expression of primary efficacy criterion : - Response to treatment taking into account the last post-baseline value (defined as a decrease of at least 50% in the initial (W0) HAM-A total score).
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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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End of the trial = the last visit of the last patient 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 | 8 |
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 | 8 |