Efficacy and Safety of RO4917523 as add-on therapy in patients with Major Depressive Disorder who have inadequate response to ongoing antidepressant medication.

• Conditions: Major Depressive Disorder (MDD); MedDRA version: 14.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-001436-33-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-27
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Primary diagnosis of Major Depressive Disorder (MDD) without psychotic features as defined by DSM-IV-TR criteria, and determined on the basis of the MINI structured interview.
• Having inadequate response to an ongoing antidepressant treatment:
• Inadequate response, defined as a CGI-S score of at least moderately ill and a priory determined level of severity in MADRS score.
• Antidepressant treatment defined as pharmacotherapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) of at least 6 weeks duration at the minimum acceptable dose.
• Dose and duration of ongoing antidepressant treatment must be verified during the screening period
• Having at least one but no more than three antidepressant treatment failures within the current depressive episode.
• Age 18 -70

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

• Currently receiving treatment with a combination of antidepressants (two or more), or on adjunctive or potentiating treatment.
• Previously received RO4917523
• Past or current use (defined a priory) of Electroconvulsive Therapy, Repetitive Transcranial Magnetic Stimulation, Vagus Nerve Stimulation, or Deep Brain Stimulation may be exclusionary
• Other current DSM-IV-TR axis I diagnosis. Comorbid anxiety which dominates the clinical presentation or troubles the patient the most is not accepted: Obszessive-Compulsive Disorder (OCD) and Posttraumatic Stress Disorder (PTSD) are specifically not allowed under an circumstances.
• Current or past history of psychotic symptoms or of Bipolar Disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified