Back to resultsA Study of RO4917523 in Patients With Treatment Resistant Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
RO4917523
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Secondary Outcome Measures
Efficacy: MADRS score
Symptoms of treatment-resistant depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00809562
Brief Title
A Study of RO4917523 in Patients With Treatment Resistant Depression
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily for 10 days
Intervention Type
Drug
Intervention Name(s)
RO4917523
Intervention Description
orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
Primary Outcome Measure Information:
Title
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Efficacy: MADRS score
Time Frame
From baseline to day 10
Title
Symptoms of treatment-resistant depression
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065-4870
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
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A Study of RO4917523 in Patients With Treatment Resistant Depression
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