E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Differential responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP) versus Escitalopram in chronic major depression with and without early trauma. |
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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 assess whether in patients with chronic Major Depressive Disorder (MDD) and early life trauma, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is superior to escitalopram plus Clinical Management in reducing depressive symptoms and leads to higher remission rates. |
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E.2.2 | Secondary objectives of the trial |
It is important to find effective treatment strategies for chronic depression since it is a common (roughly a third of all depressive disorders take a chronic course) and a particularly disabling disorder which is associated with greater comorbidity, more significant impairments in functioning, increased health care utilisation, and more frequent suicide attempts and hospitalisations than acute major depressive episodes (Arnow et al., J Clin Psychol, 2003). So far, chronic depressions are considered as treatment resistant by most clinicians. Chronically depressed patients account for a major part of the patients requiring hospitalisation |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Chronic MDD according to DSM-IV (modification: depressive symptomatology for at least one year), or recurrent MDE (third or greater episode with the immediately preceeding episode being no more than 2.5 years before the onset of the present episode) - age 18-65 - score of at least 18 on the Montgomery-Asberg-Rating Scale for Depression (MADRS)
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E.4 | Principal exclusion criteria |
- Acute risk for suicide - history of psychotic symptoms, bipolar disorder or dementia - Severe substance-related abuse or dependence disorder - Schizotypal, antisocial or borderline personality disorder - Serious medical condition - severe cognitive impairment - Absence of a response to previous adequate trial of the study medication/CBASP - Hypersensitivity to escitalopram - Treatment with a MAO-inhibitor within 1 week before the initiation of study treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
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) | 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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
CBASP (Cognitive Behavioural Analysis System of Psychotherapy) |
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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 | 2 |
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 | 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
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |