E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with bipolar disorder in a depressive episode are randomised to receive escitalopram or placebo for eight weeks. Responders to escitalopram are re-randomised to placebo or escitalopram for 32 weeks' maintenance treatment. Placebo-responders continue placebo for the whole maintenance phase. |
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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 |
The study has two principal aims: 1)To compare the efficacy and the risk of mood switching of escitalopram and placebo in the acute phase treatment of bipolar depression in patients already taking mood stabilisers. 2) to compare the efficacy of escitalopram and placebo in the continuation phase therapy for bipolar depression using a placebo-controlled discontinuation design.
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E.2.2 | Secondary objectives of the trial |
The study will compare the occurrence of syndromal and subsyndromal relapses, mixed states, mania, hypomania, and rapid cycling in the seven months following response to acute phase treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
bipolar disorder type I or II in major depressive episode according to DSM-IV (as diagnosed by the Mini International Neuropsychiatric Interview (MINI)) MADRS score of at least 20 points age 18 - 70 unchanged dose of mood stabilisers for at least six weeks prior to inclusion voluntary, informed and written consent
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E.4 | Principal exclusion criteria |
non-affective psychotic symptoms at screening or baseline pregnancy or breast-feeding fertile women without appropriate contraception substance abuse or dependence during the last three months prior to baseline mental retardation and organic brain disorders suicide risk that mandates specific measures novel (within three months) or unstable medical conditions clinically significant abnormal results on medical examination or blood samples exposure to escitalopram during the last three months allergic reactions to citalopram or escitalopram anorexia nervosa with body mass index below 18 formal psychotherapy started within six weeks of baseline electroconvulsive therapy (ECT) during the current episode of depression patients who are unlikely to be reliable and compliant with study procedures
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E.5 End points |
E.5.1 | Primary end point(s) |
For the acute phase, response and remission rates as assessed by the MADRS are the primary outcome measures. CGI-Improvement and change on the IDS-SR are secondary outcome measures. In the continuation study secondary primary outcome measures are emergence of major depressive episodes and mania/hypomania, while time spent at different depressive symptom levels as assessed by the DSM-IV diagnostic criteria are secondary outcome measures. |
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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 | 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) | 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 | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |