A Study of RO4917523 in Patients With Treatment Resistant Depression

An Exploratory Fixed Dose Randomized Double Blind Parallel-group Placebo-controlled Study of the Safety and of the Therapeutic Effects of Ro 4917523 in Patients With Treatment- Resistant Depression

This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to placebo, in patients with treatment-resistant depression. Following a washout period from existing anti-depressant medication, cohorts of patients will be randomized to receive daily oral RO4917523 at up to five different doses (according to the safety and tolerability observed at the lower doses during the study), or placebo. The anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is <100 individuals.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: RO4917523; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92056
    • San Diego, California, United States, 92103
  • Connecticut
    • New Haven, Connecticut, United States, 06511
  • Louisiana
    • Shreveport, Louisiana, United States, 71115
  • Mississippi
    • Flowood, Mississippi, United States, 39232
  • New York
    • New York, New York, United States, 10032
    • New York, New York, United States, 10029
    • New York, New York, United States, 10065-4870
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients, 18-65 years of age;
• recurrent major depressive disorder, without psychotic features;
• at least 3 lifetime treatment failures, at least 2 of which must have occurred within the current depressive episode;
• baseline minimal severity defined by a HAM-D score of 18 or above;
• willing to be hospitalized for at least 16 consecutive days.

Exclusion Criteria:

• history of bipolar disorder, schizoaffective disorder or schizophrenia;
• history of psychosis, including psychotic depression;
• significant past or present neurological disorder, including seizures, stroke and/or head trauma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RO4917523; orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
Placebo Comparator: 2	Drug: Placebo; po daily for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs	Throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy: MADRS score	From baseline to day 10
Symptoms of treatment-resistant depression	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 17, 2008

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: NP22022