E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of the study is to test augmentation of SSRI therapy with LY2422347 in patients who continue to manifest significant levels of depressive symptoms following an adequate treatment with an SSRI antidepressant. |
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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 primary objective of this study is to test the hypothesis that augmentation of SSRI therapy with 15 mg of LY2422347 taken daily for approximately 8 weeks will result in statistically significant symptom reduction in depressed patients with inadequate response to SSRI monotherapy, as compared to continued treatment with SSRI augmented with placebo. |
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E.2.2 | Secondary objectives of the trial |
- To compare the efficacy of the combination of SSRI plus LY2422347 with SSRI plus placebo as measured by the change from baseline in the SDS, in the IDS-SR, in the MPS of the HAMD-17 and in CGI-S scores. - To compare the efficacy of SSRI plus LY2422347 with SSRI plus placebo, as measured by response and remission rates - To compare the efficacy of the combination of SSRI plus LY2422347 with SSRI plus placebo on sleep as measured by AIS and on cognition, using a composite cognitive score derived from the VLRT, the SDST, the 2DCT, and the LNST. - To assess the safety and tolerability of LY2422347 relative to placebo in patients receiving ongoing SSRI therapy.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Patients must meet DSM-IV criteria for a current episode of major depression without psychotic features, as determined by clinical assessment and confirmed by semi-structured interview with the MINI at Visit 1. - Patients must have a history of at least one prior episode of major depression within the previous 3 years (determined by clinical history). - Patients should have been receiving and adequately adhering to treatment with any of the following SSRI antidepressants: sertraline, paroxetine, citalopram, or escitalopram at fixed doses of at least 150, 30, 40 or 20 mg/day, respectively, for at least 4 weeks. - In the judgment of the investigator, patients must be considered to have experienced insufficient antidepressant response from the ongoing SSRI treatment, and be considered unlikely to benefit from further increases in SSRI dose.
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E.4 | Principal exclusion criteria |
- Patients with suicidal ideation are not excluded from participation in this study. If suicidal ideation is present, however, the investigator should assess its severity and the potential need for other interventions prior to enrolling the patient, and then determine whether these are compatible with study participation. Patients considered at immediate high risk for harming themselves or others are excluded from participating in this study. - Patients with any additional, ongoing DSM-IV Axis I condition that is considered the primary diagnosis within 6 months of Visit 1 are also excluded from participation in this study. - Patients who received or are currently receiving additional antidepressant, stimulant, hormonal, mood stabilizer, anxiolytic or antipsychotic treatment for augmentation of ongoing SSRI therapy of the current major depressive episode will be excluded from participation in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be the change from baseline in the total score of the 17-item version of the Hamilton Depression Rating Scale (HAMD-17) for SSRI plus LY2422347 compared to SSRI plus placebo after up to approximately 8 weeks of therapy. |
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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 | Yes |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Yes |
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 | 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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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 | 6 |
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 | 6 |