Treatment Resistant Depression study for RO4995819

• Conditions: Major Depressive Disorder; MedDRA version: 14.1Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-002160-24-SK
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• A primary diagnosis of MDD without psychotic features
• Having inadequate response to current antidepressant treatment
• Having at least 1 but no more than 2 antidepressant treatment trial failures within the index depressive episode
• Index depressive episode started within 1 year
• 18 up to 65 years of age
• BMI between 18.0 to 35.0 kg/m2 inclusive
• Patients with reproductive potential must agree to use specified contraceptive protection

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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

• Previously received RO4995819
• History of non-response to, or current use of a non-pharmacological treatment
• Present DSM-IV-TR axis I diagnosis except anxiety comorbidity
• Past or present psychotic symptoms
• Mood disorder due to medical condition or substance use/abuse/dependence
• Established personality disorder
• Alcohol and/or substance abuse/dependence
• A current (at screening) significant risk for suicidal behavior as judged by the Investigator following a thorough clinical evaluation and supported by information collected on the C-SSRS
• Significant or unstable other medical condition that could interfere with the conduct of the study

Study & Design

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