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

A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221839

Enrollment

300

Registered

2012-06-28

Start date

2012-06-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Disorder, Major

Interventions

investigational material(s) Generic name etc : RO4917523 INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material :

0.5 mg orally daily , RO4917523

1.5 mg orally daily control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : ma

orally daily

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
MADRS Change in Montgomery Asberg Depression Rating Scale (MADRS)	—

Secondary

Measure	Time frame
- CGI-S - CGI-I - Safety - Proportion of patients exhibiting remission - Proportion of patients exhibiting response - Change in Clinical Global Impression Score - Severity (CGI-S) - Change in Clinical Global Impression Score - Improvement (CGI-I) - Safety: Incidence of adverse events - Proportion of patients exhibiting remission (MADRS /= 50% of baseline score) after 6 weeks of treatment	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026