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.
Conditions
Interventions
Product Name: Pruvanserin
Product Code: LY2422347
Pharmaceutical Form: Capsule*
CAS Number: 443144-27-2
Other descriptive name: 7-{4-[2-(4-Fluoro-phenyl)-ethyl]-piperazine-1-carbonyl}-1H-indole-3-carb
Sponsors
Eli Lilly & Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Main Objective: 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. ;Secondary Objective: - 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. | — |
Countries
Hungary, Spain
Outcome results
None listed