A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy

Phase 1

• Conditions: Depression Disorder, Major

• Registration Number: JPRN-jRCT2080221839
• Lead Sponsor: Hoffmann-La Roche Ltd, Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Adult patient, 18 to 70 years of age at time of informed consent
- Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
- Inadequate response to ongoing antidepressant treatment, as defined by protocol
- Body mass index (BMI) 18 to 38 kg/m2 inclusive

Exclusion Criteria

- Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
- Previously received RO4917523
- History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
- History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
- Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
- Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified