Effects of 5HT2A Blockade in Depressed Patients with Inadequate Antidepressant Treatment Response - N/A

Conditions: 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.

Registration Number: EUCTR2005-002430-34-HU

Lead Sponsor: Eli Lilly & Company Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 350

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

- 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.